Back to resultsClinical Investigation on the Safety and Clinical Performance of Papix Acne Scar.
Primary Purpose
Acne, Scars
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Papix acne scar
Sponsored by
About this trial
This is an interventional treatment trial for Acne focused on measuring cream, mild moderate acne, Papix, Papix acne scar, acne treatment
Eligibility Criteria
Inclusion Criteria:
- Subject's or parents or guardian (depending on the age of the subject) written informed consent obtained prior to any study-related procedures;
- Male or female subjects aged ≥ 12 years of any race;
- Subjects with any Fitzpatrick skin phototype;
- Subjects with clinical diagnosis of mild to moderate acne vulgaris (IGA score 2 or 3) on the face;
- Presence of acne scars (all types included), of grade mild or moderate according to SGA;
- Subjects with cooperative attitude, able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and able to comply with the requirements of the entire investigation (including ability to attend the planned visits according to the time limits), based on Investigator's judgement.
Exclusion Criteria:
- Pregnant women
- Severe acne at inclusion or any acne requiring systemic treatment;
- Presence of facial warts or fungal infections;
- Active dermatitis on the face, rosacea, active herpes simplex;
- Keloids presence in the area to be treated or keloids development during the treatment period;
- History of radiation or skin tumors in the/close to the area to be treated in the past 5 years;
- Laser ablative procedures within the last month;
- Chemical peels within the last 6 months;
- Use of topical treatments like antibiotics, corticosteroids, benzoyl peroxide, azelaic acid, hydroxy acids and other antinflammatory drugs within 2 weeks;
- Use of topical retinoids within 4 weeks;
- Use of systemic corticosteroids or antibiotics in the previous 30 days;
- Use of systemic spironolactone/drospirenone or immunomodulators in the previous 3 months;
- Use of oral retinoids or cyproterone acetate/chlormadinone acetate in the previous 6 months;
- Use of scrub, alpha hydroxy acid (AHA), skin irritant products in the 2 days before study treatment start;
- Subjects with any other clinically significant or unstable concurrent disease or skin condition or general condition that, in the Investigator's opinion, might interfere with the study evaluations;
- Allergy, sensitivity or intolerance to the components of the investigational device formulations ingredients;
- Concomitant or previous participation in other interventional clinical study in the past 3 months;
- Subjects planning sun exposure or tanning booths or UV sources throughout the course of the study. In case of sun exposure this shall be limited and a protection cream (SPF 50+) shall be applied.
Sites / Locations
- Ospedale San Martino
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Papix acne scar
Arm Description
Papix acne scar gel for 8 consecutive weeks, 2 times per day
Outcomes
Primary Outcome Measures
To evaluate and confirm the performance of PAPIX ACNE SCAR in the prevention and improvement of scars in subject suffering for mild to moderate acne, after 4 weeks of treatment
Indicate the proportion of subjects with improved acne scars and marks respect to baseline and, at the same time, without any new facial acne scars after 4 weeks of treatment with the change in the qualitative Scar Global Assessment (SGA) questionnaire.
Secondary Outcome Measures
To evaluate the performance of PAPIX ACNE SCAR in the prevention and improvement of scars after 2 and 8 weeks of treatment.
Indicate the proportion of subjects with improved acne scars and marks with respect to baseline and, at the same time, without any new facial acne scars after 2 and 8 weeks of treatment. The improvement of acne scars and marks will be assessed as the change in the qualitative Scar Global Assessment (SGA) questionnaire
To evaluate the performance of PAPIX ACNE SCAR in the prevention of lesions after 2, 4 and 8 weeks of treatment
Indicate the prevention of acne lesions after 2, 4 and 8 weeks of treatment.
evaluate acne severity
To evaluate acne severity after 2, 4 and 8 weeks of treatment, through the Investigator Global Assessment.
skin roughness improvement
To evaluate the improvement of the skin roughness after 2, 4 and 8 weeks of treatment.through the Investigator Global Assessment
skin texture improvement
To evaluate the change in skin texture after 2, 4 and 8 weeks of treatment, through the Investigator Global Assessment
treatment compliance
To evaluate the subject's adherence to treatment by the product accountability.
Subject and Investigator Global Evaluation of Performance
To evaluate the subject's and Investigator's global evaluation of satisfaction with regards to the performance of PAPIX ACNE SCAR through a specific questionnaire.
Treatment acceptability
To evaluate the subject's overall acceptability of the treatment through a specific questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04806594
Brief Title
Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar.
Official Title
Open Label, Uncontrolled Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar in the Prevention and Improvement of Scars and Lesions Associated With Acne
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Relife S.r.l.
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
The scope of this open label clinical trial is to evaluate and confirm the performance of Papix acne scar in the prevention and improvement of acne scars in subject suffering for mild to moderate acne. The product will be applied for 8 consecutive weeks and 3 clinical follow up visits will be performed.
Detailed Description
The scope of this open label clinical trial is to evaluate and confirm the performance of Papix acne scar in the prevention and improvement of acne scars in subject suffering for mild to moderate acne. The product will be applied for 8 consecutive weeks, 2 times per day into the face.
The dermatologist will perform 3 clinical follow up visits to assess the efficacy and safety of the product.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne, Scars
Keywords
cream, mild moderate acne, Papix, Papix acne scar, acne treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multicenter, open label, uncontrolled, single arm, post-market clinical follow-up study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Papix acne scar
Arm Type
Experimental
Arm Description
Papix acne scar gel for 8 consecutive weeks, 2 times per day
Intervention Type
Device
Intervention Name(s)
Papix acne scar
Intervention Description
PapiX acne scar, class IIa medical device, gel for acne scar. to be applied 2 times per day during the 8 weeks of study duration
Primary Outcome Measure Information:
Title
To evaluate and confirm the performance of PAPIX ACNE SCAR in the prevention and improvement of scars in subject suffering for mild to moderate acne, after 4 weeks of treatment
Description
Indicate the proportion of subjects with improved acne scars and marks respect to baseline and, at the same time, without any new facial acne scars after 4 weeks of treatment with the change in the qualitative Scar Global Assessment (SGA) questionnaire.
Time Frame
four weeks of treatment
Secondary Outcome Measure Information:
Title
To evaluate the performance of PAPIX ACNE SCAR in the prevention and improvement of scars after 2 and 8 weeks of treatment.
Description
Indicate the proportion of subjects with improved acne scars and marks with respect to baseline and, at the same time, without any new facial acne scars after 2 and 8 weeks of treatment. The improvement of acne scars and marks will be assessed as the change in the qualitative Scar Global Assessment (SGA) questionnaire
Time Frame
two weeks of treatment and 8 weeks of treatment
Title
To evaluate the performance of PAPIX ACNE SCAR in the prevention of lesions after 2, 4 and 8 weeks of treatment
Description
Indicate the prevention of acne lesions after 2, 4 and 8 weeks of treatment.
Time Frame
two weeks, 4 weeks and 8 weeks of treatment
Title
evaluate acne severity
Description
To evaluate acne severity after 2, 4 and 8 weeks of treatment, through the Investigator Global Assessment.
Time Frame
two weeks, 4 weeks and 8 weeks of treatment
Title
skin roughness improvement
Description
To evaluate the improvement of the skin roughness after 2, 4 and 8 weeks of treatment.through the Investigator Global Assessment
Time Frame
two weeks, 4 weeks and 8 weeks of treatment
Title
skin texture improvement
Description
To evaluate the change in skin texture after 2, 4 and 8 weeks of treatment, through the Investigator Global Assessment
Time Frame
two weeks, 4 weeks and 8 weeks of treatment
Title
treatment compliance
Description
To evaluate the subject's adherence to treatment by the product accountability.
Time Frame
8 weeks
Title
Subject and Investigator Global Evaluation of Performance
Description
To evaluate the subject's and Investigator's global evaluation of satisfaction with regards to the performance of PAPIX ACNE SCAR through a specific questionnaire.
Time Frame
8 weeks of treatment
Title
Treatment acceptability
Description
To evaluate the subject's overall acceptability of the treatment through a specific questionnaire.
Time Frame
8 weeks of treatment
Other Pre-specified Outcome Measures:
Title
adverse event collection
Description
To evaluate the local and general tolerability of PAPIX ACNE SCAR.
Time Frame
two weeks, 4 weeks and 8 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject's or parents or guardian (depending on the age of the subject) written informed consent obtained prior to any study-related procedures;
Male or female subjects aged ≥ 12 years of any race;
Subjects with any Fitzpatrick skin phototype;
Subjects with clinical diagnosis of mild to moderate acne vulgaris (IGA score 2 or 3) on the face;
Presence of acne scars (all types included), of grade mild or moderate according to SGA;
Subjects with cooperative attitude, able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and able to comply with the requirements of the entire investigation (including ability to attend the planned visits according to the time limits), based on Investigator's judgement.
Exclusion Criteria:
Pregnant women
Severe acne at inclusion or any acne requiring systemic treatment;
Presence of facial warts or fungal infections;
Active dermatitis on the face, rosacea, active herpes simplex;
Keloids presence in the area to be treated or keloids development during the treatment period;
History of radiation or skin tumors in the/close to the area to be treated in the past 5 years;
Laser ablative procedures within the last month;
Chemical peels within the last 6 months;
Use of topical treatments like antibiotics, corticosteroids, benzoyl peroxide, azelaic acid, hydroxy acids and other antinflammatory drugs within 2 weeks;
Use of topical retinoids within 4 weeks;
Use of systemic corticosteroids or antibiotics in the previous 30 days;
Use of systemic spironolactone/drospirenone or immunomodulators in the previous 3 months;
Use of oral retinoids or cyproterone acetate/chlormadinone acetate in the previous 6 months;
Use of scrub, alpha hydroxy acid (AHA), skin irritant products in the 2 days before study treatment start;
Subjects with any other clinically significant or unstable concurrent disease or skin condition or general condition that, in the Investigator's opinion, might interfere with the study evaluations;
Allergy, sensitivity or intolerance to the components of the investigational device formulations ingredients;
Concomitant or previous participation in other interventional clinical study in the past 3 months;
Subjects planning sun exposure or tanning booths or UV sources throughout the course of the study. In case of sun exposure this shall be limited and a protection cream (SPF 50+) shall be applied.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurora Parodi
Organizational Affiliation
Ospedale Policlinico San Martino, Genova
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar.
We'll reach out to this number within 24 hrs