Back to resultsAnti-acne Efficacy of a Dermo-cosmetic Product Associated With the Fixed Combination Adapalene 0.1%/ Benzoyl Peroxide 2.5% Treatment Versus This Treatment Associated With a Standard Moisturizer in Male and Female Subjects Presenting With Mild to Moderate Acne
Primary Purpose
Acne
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Epiduo
Salicylic Acid
Hydréane légère
Sponsored by
About this trial
This is an interventional treatment trial for Acne
Eligibility Criteria
Inclusion Criteria:
- Male and/or female subjects aged 16 to 35 years
- Subjects presenting with mild to moderate acne (stage 2 or stage 3 with at least 12 inflammatory lesions on face according to the Global Acne Evaluation)
Female subjects of child-bearing potential who:
- use the same reliable hormonal contraceptive method (oral contraceptive, implant, intra-uterine device, patch, cervical cap, vaginal ring and injection) for at least 3 months prior to study inclusion and throughout the study or
- use a reliable non-hormonal contraceptive method (copper intra-uterine device, condoms, diaphragm, cervical cap and spermicide) for at least 1 month prior to study inclusion and throughout the study or
- have no sexual intercourse and agreeing not to have any throughout the study or
- are surgically sterile (oophorectomy, hysterectomy or tubal ligation),
- Subjects and/or all legal representatives (for minor subjects) who have given written informed consent
- Subjects who are willing to comply with the study requirements
- Subjects with Social Security (health insurance) coverage (according to the French requirements)
Exclusion Criteria:
- Subjects with any systemic disorder or face dermatoses other than acne that would in any way confound interpretation of the study results (e.g. atopic dermatitis, eczema, or psoriasis)
- Subjects with a condition or receiving a medication and/or with a history of medical/surgical events which, in the opinion of the Investigator, could compromise the safety of the subject or affect the outcome of the study
- Subjects with a history of skin cancer
- Female subjects who are pregnant (positive urine pregnancy test) or lactating or who are planning to become pregnant during the study
- Subjects who have started, stopped or changed of hormonal treatment (contraception, thyroid …) in the 3 months prior the study inclusion
- Subjects with hypersensitivity to the active substances of Epiduo (Adapalene and/or benzoyl peroxide) or to one of its excipients
- Subjects who are sensitive to peroxides (oxygenated water)
- Subjects who have received isotretinoin treatment in the 6 months prior to study inclusion
- Subjects who have been exposed to excessive UV light (natural or artificial) in the 1 month prior to the study inclusion or having planned excessive UV light exposure during the study (e.g. ski holidays, holidays in the tropics…)
- Subjects who have used systemic drugs for more than 3 consecutive days related to antibiotics, anti-inflammatory, corticoids, anti-acneic in the 4 weeks prior to study inclusion
- Subjects who have used topical drugs for more than 3 consecutive days related to antibiotics, anti-inflammatory, corticoids, anti-acneic in the 2 weeks prior to study inclusion
- Subjects who have used scrub, anti-seborrheic topical cosmetic products and/or who have applied self-tanning products on face in the 1 week prior the study inclusion
- Subjects who have applied cosmetic products for more than 5 consecutive days with alpha hydroxyl-acids, vitamin C, hyaluronic acids in the 1 week prior the study inclusion
- Subjects having washed the face and/or the hair the day of the study inclusion (only water is accepted the morning of the study inclusion)
- Subjects having applied any topical products on face (including make-up) the day of the study inclusion
- Subjects who have planned a major surgery during the study requiring hospitalization under general anesthesia and the use of systemic or topical drugs (e.g. antibiotics, anti-inflammatory) for more than 1 week
- Subjects who declare to be deprived of their freedom by administrative or legal decision or who are under guardianship
- Subjects who cannot be contacted by telephone in case of emergency
- Subjects belonging to the staff of the study centre
- Subjects in an exclusion period or participating in another biomedical research study
Sites / Locations
- INTERTEK
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Salicylic acid & Epiduo 0.1%-2.5% Topical Gel
Hydréane légère & Epiduo 0.1%-2.5% Topical Gel
Arm Description
Salicylic acid: Once-a-day, on the morning, during 12 weeks. Epiduo gel: Once-a-day, on the evening (before bedtime) during 12 weeks.
Hydréane légère: Once-a-day, on the morning, during 12 weeks. Epiduo gel: Once-a-day, on the evening (before bedtime) during 12 weeks.
Outcomes
Primary Outcome Measures
Evaluation of the anti-acne efficacy 1 (number of the retentional and inflammatory lesions)
Change in the number of the retentional (open & closed comedones) and inflammatory lesions (papulae, pustulae & nodules (if applicable)) on face after a 12-week application period At Week 0 (before any application) and Week 12 (after a 12-week application period), a counting of the retentional (open & closed comedones) and inflammatory lesions (papulae, pustulae & nodules (if applicable)) will be performed by a Dermatologist.
The counting will be broken down on several parts of the face (forehead, left and right cheeks and chin).
Secondary Outcome Measures
Evaluation of the anti-acne efficacy 2 (number of the retentional and inflammatory lesions)
Change in the number of the retentional (open & closed comedones) and inflammatory lesions (papulae, pustulae & nodules (if applicable)) on face after 4 and 8-week application period At Week 4 (after a 4-week application) and Week 8 (after a 8-week application period), a counting of the retentional (open & closed comedones) and inflammatory lesions (papulae, pustulae & nodules (if applicable)) will be performed by a Dermatologist.
The counting will be broken down on several parts of the face (forehead, left and right cheeks and chin).
Change in the acne stage on face according to the Global Acne Evaluation scale after 4, 8 and 12-week application period
At Week 0 (before any application), Week 4 (after a 4-week application period), Week 8 (after an 8-week application period) and Week 12 (after a 12-week application period), determination of the acne stage will be performed by the Dermatologist according to the Global Acne Evaluation scale (score min:0 to score max:5). More the score decreased, more the treatment is efficient.
Change in the residual marks visibility after 4, 8 and 12-week application period
At Week 0 (before any application), Week 4 (after a 4-week application period), Week 8 (after an 8-week application period) and Week 12 (after a 12-week application period), the residual marks visibility of acne (hyperpigmentation) will be assessed under the same conditions by the Dermatologist using the scale below which include 10 grades (0: absence to 9:numerous). More the score decreased, more the treatment is efficient.
Change in the pores visibility after 4, 8 and 12-week application period
At Week 0 (before any application), Week 4 (after a 4-week application period), Week 8 (after an 8-week application period) and Week 12 (after a 12-week application period), the pores visibility will be assessed under the same conditions by the Dermatologist using the scale below which include 10 grades (0: absence to 9:numerous). More the score decreased, more the treatment is efficient.
Change in the skin shininess after 4, 8 and 12-week application period
At Week 0 (before any application), Week 4 (after a 4-week application period), Week 8 (after an 8-week application period) and Week 12 (after a 12-week application period), the skin shininess will be assessed under the same conditions by the Dermatologist using the scale below which include 10 grades (0: absence to 9:high). More the score decreased, more the treatment is efficient.
Change in skin greasiness after 4, 8 and 12-week application period
At Week 0, Week 4, Week 8 and Week 12, instrumental measurements will be performed by a technician/a nurse.
The CL measurements (quantity of sebum (casual level)) will be taken using a SEBUMETER®.
The unit is in µg sebum/cm² of the skin. Only one measurement per subject will be taken in the middle of the forehead. More the value decreased, less the skin is greasy.
Change in skin moisturizing after 4, 8 and 12-week application period
At Week 0, Week 4, Week 8 and Week 12, instrumental measurements will be performed by a technician/a nurse.
The measurements will be taken using a CM 825 PC CORNEOMETER®. The hydratation values are expressed in arbitrary units ranging from approximately 0 to 120.
Three measurements per subject will be taken on the right cheekbone. More the value increased, more the skin is moisturize.
Change in skin ph after 4, 8 and 12-week application period
At Week 0, Week 4, Week 8 and Week 12, instrumental measurements will be performed by a technician/a nurse.
The measurements will be taken using a SKIN PH METER 900®. The result will be expressed in pH units. Only one measurement per subject will be taken on the left cheek, near to the side of the nose. More the value decreased, more the ph is acid.
Total number of hair follicles per cube at a mean depth of 38 µm after a 12-week application period
At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.
Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).
Confocal images will be analyzed by two confocal microscopy experts.
Diameter of the infundibulum in µm after a 12-week application period
At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.
Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).
Confocal images will be analyzed by two confocal microscopy experts.
Aspect of the border (thickness) (number and percentage) after a 12-week application period
At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.
Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).
Confocal images will be analyzed by two confocal microscopy experts.
Onion like appearence (number and percentage) after a 12-week application period
At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.
Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).
Confocal images will be analyzed by two confocal microscopy experts.
Presence of amorphous material into the infundibulum (number and percentage) after a 12-week application period
At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.
Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).
Confocal images will be analyzed by two confocal microscopy experts.
Signs of inflammation (number and percentage) after a 12-week application period
At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.
Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).
Confocal images will be analyzed by two confocal microscopy experts.
Vascularization (number and percentage) after a 12-week application period
At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.
Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).
Confocal images will be analyzed by two confocal microscopy experts.
Presence of Demodex mites (number and percentage) after a 12-week application period
At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.
Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).
Confocal images will be analyzed by two confocal microscopy experts.
Analysis of the efficacy on the skin quality using a questionnaire
Subjects will complete an efficacy questionnaire at the last visit (after a 12-week application period of the Investigational Product (cosmetic product & drug)).
The following items will be evaluated by the subjects:
Imperfections are less visible
The skin is cleansed/purified
The complexion is homogeneous / uniform
The skin is comfortable
The skin is like hydrated
The skin is smoother
The skin is softer
The skin is suppler
The skin is less brilliant
The skin is matified
Excess sebum is reduced
The skin has a matte touch
The pores of the skin are tightened
Redness of the skin are reduced
The skin texture is refined
The marks of the skin are less visible
The following scale will be used:
Agree ("D'accord")
Somewhat agree ("Plutôt d'accord")
Neither agree, nor disagree ("Ni d'accord ni pas d'accord")
Somewhat disagree ("Plutôt pas d'accord")
Disagree ("Pas d'accord")
Analysis of the local tolerance using clinical assessments
At Week 0 (before any application), Week 4 (after a 4-week application period), Week 8 (after an 8-week application period) and Week 12 (after a 12-week application period), a clinical assessment of the face skin condition will be performed by the Dermatologist:
Physical signs: erythema, dryness and scaling
Functional signs*: tightness, prickling, itching, burning sensation and others
The following scale will be used:
Rating 0: none ("absence") Rating 1: slight ("léger") Rating 2: moderate ("modéré") Rating 3: severe ("sévère")
* During the study, the subjects will have to record any skin discomfort, intensity (slight, moderate or severe) and duration in their daily log. Functional signs will be assessed by the Dermatologist from a review of the daily log and interrogatory of the subject.
In addition, at W12 (after a 12-week application period), the Dermatologist and the subject.
Products overall tolerance appreciation by the Dermatologist and the subject
In addition, at Week 12 (after a 12-week application period), the Dermatologist and the subject will state about the overall tolerance of the IP (cosmetic product & drug) based on rating scale:
Excellent tolerance
Good tolerance
Medium tolerance
Poor tolerance
Analysis of the cosmetic acceptability using a questionnaire
Subjects will complete a cosmetic acceptability questionnaire concerning the cosmetic product at the last visit.
The following items will be evaluated by the subjects:
The product is easy to spread
The product is easy to apply
The product penetrates quickly
The color of the product is pleasant
The scent of the product is pleasant
The aspect of the product is pleasant
The texture of the product is pleasant
The texture is comfortable
The product doesn't leave the skin sticky
The product doesn't leave a greasy film on the skin
The product leaves a silky effect
The product does not go noodles
The following scale will be used:
Agree ("D'accord")
Somewhat agree ("Plutôt d'accord")
Neither agree, nor disagree ("Ni d'accord ni pas d'accord")
Somewhat disagree ("Plutôt pas d'accord")
Disagree ("Pas d'accord")
Evaluation of the skin microbiota using sampling (if applicable)
At Week 0 and at Week 12, microbiota sampling will be performed by the same sampler (technician/nurse).
Skin microbiota sample will be collected on one test site of 4 cm2 on the middle of the left cheek and using aseptic techniques under sterile airflow generated by a portable hood.
According to the results of the primary variable, the Sponsor will decide to go ahead with the microbiota analysis which will be done by INRA Transfert.
DNA will be extracted from the swabs. PCR amplification will be performed for each DNA sample. DNA will be PCR amplified. Cleaned pools will be sequenced on the Illumina MiSeq platform.
Sequences will be then de-replicated and a database containing one sequence for each operational taxonomic unit will be generated.
Interpretation of these results will be done by Mercurialis.
Analysis of the number of subject with adverse event related to the study product
Adverse Events will be collected during all the study from Week 0 to Week 12
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03832647
Brief Title
Anti-acne Efficacy of a Dermo-cosmetic Product Associated With the Fixed Combination Adapalene 0.1%/ Benzoyl Peroxide 2.5% Treatment Versus This Treatment Associated With a Standard Moisturizer in Male and Female Subjects Presenting With Mild to Moderate Acne
Official Title
Multicentric, Parallel, Randomized, Double Blind Study Under Dermatological Control to Evaluate the Anti-acne Efficacy of a Dermo-cosmetic Product (Fla 688977 33) Associated With the Fixed Combination Adapalene 0.1%/ Benzoyl Peroxide 2.5% Treatment Versus This Treatment Associated With a Standard Moisturizer (Hydréane légère, Cosmétique Active International) During a 12-week Application Period in Male and Female Subjects Presenting With Mild to Moderate Acne
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 18, 2019 (Actual)
Primary Completion Date
February 17, 2020 (Actual)
Study Completion Date
February 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vichy Laboratoires
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study to evaluate the anti-acne efficacy of a dermo-cosmetic associated with the fixed combination Adapalene 0.1%/ benzoyl peroxide 2.5% treatment and to demonstrate that the dermo-cosmetic product can improve the local tolerance of the fixed combination Adapalene 0.1%/ benzoyl peroxide 2.5% treatment
Multi centre, Randomised, Double blind, Controlled, Parallel (100 subjects per arm), Intra-subject & inter subject comparisons
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
100 subjects per arm
Masking
ParticipantInvestigator
Masking Description
double blind
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Salicylic acid & Epiduo 0.1%-2.5% Topical Gel
Arm Type
Experimental
Arm Description
Salicylic acid: Once-a-day, on the morning, during 12 weeks.
Epiduo gel: Once-a-day, on the evening (before bedtime) during 12 weeks.
Arm Title
Hydréane légère & Epiduo 0.1%-2.5% Topical Gel
Arm Type
Placebo Comparator
Arm Description
Hydréane légère: Once-a-day, on the morning, during 12 weeks.
Epiduo gel: Once-a-day, on the evening (before bedtime) during 12 weeks.
Intervention Type
Combination Product
Intervention Name(s)
Epiduo
Intervention Description
100 per arm Adapalene/ Benzoyl Peroxide
Intervention Type
Drug
Intervention Name(s)
Salicylic Acid
Intervention Description
Salicylic Acid
Intervention Type
Other
Intervention Name(s)
Hydréane légère
Intervention Description
moisturizer
Primary Outcome Measure Information:
Title
Evaluation of the anti-acne efficacy 1 (number of the retentional and inflammatory lesions)
Description
Change in the number of the retentional (open & closed comedones) and inflammatory lesions (papulae, pustulae & nodules (if applicable)) on face after a 12-week application period At Week 0 (before any application) and Week 12 (after a 12-week application period), a counting of the retentional (open & closed comedones) and inflammatory lesions (papulae, pustulae & nodules (if applicable)) will be performed by a Dermatologist.
The counting will be broken down on several parts of the face (forehead, left and right cheeks and chin).
Time Frame
Week 0 (baseline) and Week 12 (final time point)
Secondary Outcome Measure Information:
Title
Evaluation of the anti-acne efficacy 2 (number of the retentional and inflammatory lesions)
Description
Change in the number of the retentional (open & closed comedones) and inflammatory lesions (papulae, pustulae & nodules (if applicable)) on face after 4 and 8-week application period At Week 4 (after a 4-week application) and Week 8 (after a 8-week application period), a counting of the retentional (open & closed comedones) and inflammatory lesions (papulae, pustulae & nodules (if applicable)) will be performed by a Dermatologist.
The counting will be broken down on several parts of the face (forehead, left and right cheeks and chin).
Time Frame
Week 4 and Week 8 (intermediary times point)
Title
Change in the acne stage on face according to the Global Acne Evaluation scale after 4, 8 and 12-week application period
Description
At Week 0 (before any application), Week 4 (after a 4-week application period), Week 8 (after an 8-week application period) and Week 12 (after a 12-week application period), determination of the acne stage will be performed by the Dermatologist according to the Global Acne Evaluation scale (score min:0 to score max:5). More the score decreased, more the treatment is efficient.
Time Frame
Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)
Title
Change in the residual marks visibility after 4, 8 and 12-week application period
Description
At Week 0 (before any application), Week 4 (after a 4-week application period), Week 8 (after an 8-week application period) and Week 12 (after a 12-week application period), the residual marks visibility of acne (hyperpigmentation) will be assessed under the same conditions by the Dermatologist using the scale below which include 10 grades (0: absence to 9:numerous). More the score decreased, more the treatment is efficient.
Time Frame
Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)
Title
Change in the pores visibility after 4, 8 and 12-week application period
Description
At Week 0 (before any application), Week 4 (after a 4-week application period), Week 8 (after an 8-week application period) and Week 12 (after a 12-week application period), the pores visibility will be assessed under the same conditions by the Dermatologist using the scale below which include 10 grades (0: absence to 9:numerous). More the score decreased, more the treatment is efficient.
Time Frame
Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)
Title
Change in the skin shininess after 4, 8 and 12-week application period
Description
At Week 0 (before any application), Week 4 (after a 4-week application period), Week 8 (after an 8-week application period) and Week 12 (after a 12-week application period), the skin shininess will be assessed under the same conditions by the Dermatologist using the scale below which include 10 grades (0: absence to 9:high). More the score decreased, more the treatment is efficient.
Time Frame
Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)
Title
Change in skin greasiness after 4, 8 and 12-week application period
Description
At Week 0, Week 4, Week 8 and Week 12, instrumental measurements will be performed by a technician/a nurse.
The CL measurements (quantity of sebum (casual level)) will be taken using a SEBUMETER®.
The unit is in µg sebum/cm² of the skin. Only one measurement per subject will be taken in the middle of the forehead. More the value decreased, less the skin is greasy.
Time Frame
Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)
Title
Change in skin moisturizing after 4, 8 and 12-week application period
Description
At Week 0, Week 4, Week 8 and Week 12, instrumental measurements will be performed by a technician/a nurse.
The measurements will be taken using a CM 825 PC CORNEOMETER®. The hydratation values are expressed in arbitrary units ranging from approximately 0 to 120.
Three measurements per subject will be taken on the right cheekbone. More the value increased, more the skin is moisturize.
Time Frame
Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)
Title
Change in skin ph after 4, 8 and 12-week application period
Description
At Week 0, Week 4, Week 8 and Week 12, instrumental measurements will be performed by a technician/a nurse.
The measurements will be taken using a SKIN PH METER 900®. The result will be expressed in pH units. Only one measurement per subject will be taken on the left cheek, near to the side of the nose. More the value decreased, more the ph is acid.
Time Frame
Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)
Title
Total number of hair follicles per cube at a mean depth of 38 µm after a 12-week application period
Description
At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.
Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).
Confocal images will be analyzed by two confocal microscopy experts.
Time Frame
Week 0 (baseline) and Week 12 (final time point)
Title
Diameter of the infundibulum in µm after a 12-week application period
Description
At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.
Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).
Confocal images will be analyzed by two confocal microscopy experts.
Time Frame
Week 0 (baseline) and Week 12 (final time point)
Title
Aspect of the border (thickness) (number and percentage) after a 12-week application period
Description
At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.
Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).
Confocal images will be analyzed by two confocal microscopy experts.
Time Frame
Week 0 (baseline) and Week 12 (final time point)
Title
Onion like appearence (number and percentage) after a 12-week application period
Description
At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.
Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).
Confocal images will be analyzed by two confocal microscopy experts.
Time Frame
Week 0 (baseline) and Week 12 (final time point)
Title
Presence of amorphous material into the infundibulum (number and percentage) after a 12-week application period
Description
At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.
Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).
Confocal images will be analyzed by two confocal microscopy experts.
Time Frame
Week 0 (baseline) and Week 12 (final time point)
Title
Signs of inflammation (number and percentage) after a 12-week application period
Description
At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.
Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).
Confocal images will be analyzed by two confocal microscopy experts.
Time Frame
Week 0 (baseline) and Week 12 (final time point)
Title
Vascularization (number and percentage) after a 12-week application period
Description
At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.
Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).
Confocal images will be analyzed by two confocal microscopy experts.
Time Frame
Week 0 (baseline) and Week 12 (final time point)
Title
Presence of Demodex mites (number and percentage) after a 12-week application period
Description
At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.
Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).
Confocal images will be analyzed by two confocal microscopy experts.
Time Frame
Week 0 (baseline) and Week 12 (final time point)
Title
Analysis of the efficacy on the skin quality using a questionnaire
Description
Subjects will complete an efficacy questionnaire at the last visit (after a 12-week application period of the Investigational Product (cosmetic product & drug)).
The following items will be evaluated by the subjects:
Imperfections are less visible
The skin is cleansed/purified
The complexion is homogeneous / uniform
The skin is comfortable
The skin is like hydrated
The skin is smoother
The skin is softer
The skin is suppler
The skin is less brilliant
The skin is matified
Excess sebum is reduced
The skin has a matte touch
The pores of the skin are tightened
Redness of the skin are reduced
The skin texture is refined
The marks of the skin are less visible
The following scale will be used:
Agree ("D'accord")
Somewhat agree ("Plutôt d'accord")
Neither agree, nor disagree ("Ni d'accord ni pas d'accord")
Somewhat disagree ("Plutôt pas d'accord")
Disagree ("Pas d'accord")
Time Frame
Week 12 (final time point)
Title
Analysis of the local tolerance using clinical assessments
Description
At Week 0 (before any application), Week 4 (after a 4-week application period), Week 8 (after an 8-week application period) and Week 12 (after a 12-week application period), a clinical assessment of the face skin condition will be performed by the Dermatologist:
Physical signs: erythema, dryness and scaling
Functional signs*: tightness, prickling, itching, burning sensation and others
The following scale will be used:
Rating 0: none ("absence") Rating 1: slight ("léger") Rating 2: moderate ("modéré") Rating 3: severe ("sévère")
* During the study, the subjects will have to record any skin discomfort, intensity (slight, moderate or severe) and duration in their daily log. Functional signs will be assessed by the Dermatologist from a review of the daily log and interrogatory of the subject.
In addition, at W12 (after a 12-week application period), the Dermatologist and the subject.
Time Frame
Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)
Title
Products overall tolerance appreciation by the Dermatologist and the subject
Description
In addition, at Week 12 (after a 12-week application period), the Dermatologist and the subject will state about the overall tolerance of the IP (cosmetic product & drug) based on rating scale:
Excellent tolerance
Good tolerance
Medium tolerance
Poor tolerance
Time Frame
Week 12 (final time point)
Title
Analysis of the cosmetic acceptability using a questionnaire
Description
Subjects will complete a cosmetic acceptability questionnaire concerning the cosmetic product at the last visit.
The following items will be evaluated by the subjects:
The product is easy to spread
The product is easy to apply
The product penetrates quickly
The color of the product is pleasant
The scent of the product is pleasant
The aspect of the product is pleasant
The texture of the product is pleasant
The texture is comfortable
The product doesn't leave the skin sticky
The product doesn't leave a greasy film on the skin
The product leaves a silky effect
The product does not go noodles
The following scale will be used:
Agree ("D'accord")
Somewhat agree ("Plutôt d'accord")
Neither agree, nor disagree ("Ni d'accord ni pas d'accord")
Somewhat disagree ("Plutôt pas d'accord")
Disagree ("Pas d'accord")
Time Frame
Week 12 (final time point)
Title
Evaluation of the skin microbiota using sampling (if applicable)
Description
At Week 0 and at Week 12, microbiota sampling will be performed by the same sampler (technician/nurse).
Skin microbiota sample will be collected on one test site of 4 cm2 on the middle of the left cheek and using aseptic techniques under sterile airflow generated by a portable hood.
According to the results of the primary variable, the Sponsor will decide to go ahead with the microbiota analysis which will be done by INRA Transfert.
DNA will be extracted from the swabs. PCR amplification will be performed for each DNA sample. DNA will be PCR amplified. Cleaned pools will be sequenced on the Illumina MiSeq platform.
Sequences will be then de-replicated and a database containing one sequence for each operational taxonomic unit will be generated.
Interpretation of these results will be done by Mercurialis.
Time Frame
Week 0 (baseline) and Week 12 (final time point)
Title
Analysis of the number of subject with adverse event related to the study product
Description
Adverse Events will be collected during all the study from Week 0 to Week 12
Time Frame
From Week 0 (baseline) to Week 12 (final time point)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and/or female subjects aged 16 to 35 years
Subjects presenting with mild to moderate acne (stage 2 or stage 3 with at least 12 inflammatory lesions on face according to the Global Acne Evaluation)
Female subjects of child-bearing potential who:
use the same reliable hormonal contraceptive method (oral contraceptive, implant, intra-uterine device, patch, cervical cap, vaginal ring and injection) for at least 3 months prior to study inclusion and throughout the study or
use a reliable non-hormonal contraceptive method (copper intra-uterine device, condoms, diaphragm, cervical cap and spermicide) for at least 1 month prior to study inclusion and throughout the study or
have no sexual intercourse and agreeing not to have any throughout the study or
are surgically sterile (oophorectomy, hysterectomy or tubal ligation),
Subjects and/or all legal representatives (for minor subjects) who have given written informed consent
Subjects who are willing to comply with the study requirements
Subjects with Social Security (health insurance) coverage (according to the French requirements)
Exclusion Criteria:
Subjects with any systemic disorder or face dermatoses other than acne that would in any way confound interpretation of the study results (e.g. atopic dermatitis, eczema, or psoriasis)
Subjects with a condition or receiving a medication and/or with a history of medical/surgical events which, in the opinion of the Investigator, could compromise the safety of the subject or affect the outcome of the study
Subjects with a history of skin cancer
Female subjects who are pregnant (positive urine pregnancy test) or lactating or who are planning to become pregnant during the study
Subjects who have started, stopped or changed of hormonal treatment (contraception, thyroid …) in the 3 months prior the study inclusion
Subjects with hypersensitivity to the active substances of Epiduo (Adapalene and/or benzoyl peroxide) or to one of its excipients
Subjects who are sensitive to peroxides (oxygenated water)
Subjects who have received isotretinoin treatment in the 6 months prior to study inclusion
Subjects who have been exposed to excessive UV light (natural or artificial) in the 1 month prior to the study inclusion or having planned excessive UV light exposure during the study (e.g. ski holidays, holidays in the tropics…)
Subjects who have used systemic drugs for more than 3 consecutive days related to antibiotics, anti-inflammatory, corticoids, anti-acneic in the 4 weeks prior to study inclusion
Subjects who have used topical drugs for more than 3 consecutive days related to antibiotics, anti-inflammatory, corticoids, anti-acneic in the 2 weeks prior to study inclusion
Subjects who have used scrub, anti-seborrheic topical cosmetic products and/or who have applied self-tanning products on face in the 1 week prior the study inclusion
Subjects who have applied cosmetic products for more than 5 consecutive days with alpha hydroxyl-acids, vitamin C, hyaluronic acids in the 1 week prior the study inclusion
Subjects having washed the face and/or the hair the day of the study inclusion (only water is accepted the morning of the study inclusion)
Subjects having applied any topical products on face (including make-up) the day of the study inclusion
Subjects who have planned a major surgery during the study requiring hospitalization under general anesthesia and the use of systemic or topical drugs (e.g. antibiotics, anti-inflammatory) for more than 1 week
Subjects who declare to be deprived of their freedom by administrative or legal decision or who are under guardianship
Subjects who cannot be contacted by telephone in case of emergency
Subjects belonging to the staff of the study centre
Subjects in an exclusion period or participating in another biomedical research study
Facility Information:
Facility Name
INTERTEK
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28573779
Citation
Bouloc A, Roo E, Imko-Walczuk B, Moga A, Chadoutaud B, Dreno B. A skincare combined with combination of adapalene and benzoyl peroxide provides a significant adjunctive efficacy and local tolerance benefit in adult women with mild acne. J Eur Acad Dermatol Venereol. 2017 Oct;31(10):1727-1731. doi: 10.1111/jdv.14379. Epub 2017 Jul 7.
Results Reference
result
PubMed Identifier
29369333
Citation
Muguet Guenot L, Vourc'h Jourdain M, Saint-Jean M, Corvec S, Gaultier A, Khammari A, Le Moigne M, Boisrobert A, Paugam C, Dreno B. Confocal microscopy in adult women with acne. Int J Dermatol. 2018 Mar;57(3):278-283. doi: 10.1111/ijd.13910. Epub 2018 Jan 25.
Results Reference
result
PubMed Identifier
27177989
Citation
Gollnick HP, Bettoli V, Lambert J, Araviiskaia E, Binic I, Dessinioti C, Galadari I, Ganceviciene R, Ilter N, Kaegi M, Kemeny L, Lopez-Estebaranz JL, Massa A, Oprica C, Sinclair W, Szepietowski JC, Dreno B. A consensus-based practical and daily guide for the treatment of acne patients. J Eur Acad Dermatol Venereol. 2016 Sep;30(9):1480-90. doi: 10.1111/jdv.13675. Epub 2016 May 14.
Results Reference
result
PubMed Identifier
27514932
Citation
Nast A, Dreno B, Bettoli V, Bukvic Mokos Z, Degitz K, Dressler C, Finlay AY, Haedersdal M, Lambert J, Layton A, Lomholt HB, Lopez-Estebaranz JL, Ochsendorf F, Oprica C, Rosumeck S, Simonart T, Werner RN, Gollnick H. European evidence-based (S3) guideline for the treatment of acne - update 2016 - short version. J Eur Acad Dermatol Venereol. 2016 Aug;30(8):1261-8. doi: 10.1111/jdv.13776. No abstract available.
Results Reference
result
PubMed Identifier
26897386
Citation
Zaenglein AL, Pathy AL, Schlosser BJ, Alikhan A, Baldwin HE, Berson DS, Bowe WP, Graber EM, Harper JC, Kang S, Keri JE, Leyden JJ, Reynolds RV, Silverberg NB, Stein Gold LF, Tollefson MM, Weiss JS, Dolan NC, Sagan AA, Stern M, Boyer KM, Bhushan R. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016 May;74(5):945-73.e33. doi: 10.1016/j.jaad.2015.12.037. Epub 2016 Feb 17. Erratum In: J Am Acad Dermatol. 2020 Jun;82(6):1576.
Results Reference
result
Learn more about this trial
Anti-acne Efficacy of a Dermo-cosmetic Product Associated With the Fixed Combination Adapalene 0.1%/ Benzoyl Peroxide 2.5% Treatment Versus This Treatment Associated With a Standard Moisturizer in Male and Female Subjects Presenting With Mild to Moderate Acne
We'll reach out to this number within 24 hrs