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Assessment of Skin Tolerance and Efficacy of a Cosmetic Product After 5 Days of Use on Subjects With Atopic Dermatitis

Primary Purpose

Atopic Diathesis, Eczema-prone Skin

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Atopi intensive care BNO 3731
Benchmark product
Sponsored by
Bionorica SE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atopic Diathesis

Eligibility Criteria

6 Months - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Written Informed Consent of the subject to participate in the study, or, for underaged subjects of the parents/ legal guardians to let their child participate in the study Willingness to actively participate in the study and to come to the scheduled visits or, for underaged subjects, willingness of the parents/ legal guardians to actively support their child's participation in the study and to come to the scheduled visits with their child Female and/or male Children from 6 months to 14 years of age and Adult subjects between 18 and 65 years of age Eczema-prone skin and atopic diathesis, diagnosed by the dermatologist Exclusion Criteria: Female subjects: Pregnancy or lactation Drug addicts, alcoholics AIDS, HIV-positive or infectious hepatitis Conditions which exclude a participation or might influence the test reaction/evaluation Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years Insulin-dependent diabetes mellitus One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases Documented allergies to cosmetic products and/ or ingredients, skin care and/or skin cleansing products Wounds, moles, tattoos, scars, excessive hair growth, etc. at the test area that could influence the investigation Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study Systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac), except for minor pain relief medicine like acetylsalicylic acid or paracetamol within the last 3 days prior to the start of the study

Sites / Locations

  • SGS proderm GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Atopi intensive care BNO 3731 for topical use

Benchmark skin care product for topical use

Arm Description

Outcomes

Primary Outcome Measures

Mean change from baseline in transepidermal water loss (g/m2h)
Mean change from baseline in skin redness by Chromameter
Mean change from baseline in skin hydration (Skin capacitance by Corneometer [a.u.])
Changes from baseline in objective dermatological evaluation of skin status (erythema, dryness, scaling, fissures, papules, pustules, edema, vesicles, weeping) by dermatologist (min=0, max=3; 3=worse outcome)

Secondary Outcome Measures

Change from baseline in the scoring of subjective dermatological evaluation via questionnaire (adults) (min=0, max=3; 3=worse outcome)
Subjective evaluation of itch on Numeric Rating Scale (NRS-11) (min= 0, max=10, 10 = worst imaginable itch)
Evaluation of products traits via questionnaire (20 questions with different answers, no scales)
Safety of BNO 3732 measured by reported Adverse Events

Full Information

First Posted
February 15, 2023
Last Updated
March 28, 2023
Sponsor
Bionorica SE
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1. Study Identification

Unique Protocol Identification Number
NCT05807113
Brief Title
Assessment of Skin Tolerance and Efficacy of a Cosmetic Product After 5 Days of Use on Subjects With Atopic Dermatitis
Official Title
Assessment of Skin Tolerance and Efficacy of a Cosmetic Product After 5 Days of Use on Subjects With Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
February 22, 2022 (Actual)
Study Completion Date
February 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bionorica SE

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 aim of this study is to compare the efficacy and tolerability and of a cosmetic product to one that is already available on the market (benchmark product). Efficacy is assessed by instrumental measurements of skin condition, clinical examinations, and questionnaires.
Detailed Description
The objective of this exploratory study is to investigate the efficacy and tolerability of a cosmetic product on subjects with atopic dermatitis after 5 days of use in comparison to a benchmark product. The efficacy will be evaluated via instrumental measurements of skin hydration by Corneometer, transepidermal water loss by Tewameter and erythema by Chromameter as well as by evaluation of itch by using a Numerical Rating Scale (NRS). For efficacy and tolerability evaluation an objective and, in the case of adults, an additional subjective dermatological assessment will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Diathesis, Eczema-prone Skin

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
intra-individual comparison
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atopi intensive care BNO 3731 for topical use
Arm Type
Experimental
Arm Title
Benchmark skin care product for topical use
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Atopi intensive care BNO 3731
Intervention Description
Crem twice daily
Intervention Type
Other
Intervention Name(s)
Benchmark product
Intervention Description
Crem twice daily
Primary Outcome Measure Information:
Title
Mean change from baseline in transepidermal water loss (g/m2h)
Time Frame
after 6 days of treatment
Title
Mean change from baseline in skin redness by Chromameter
Time Frame
after 6 days of treatment
Title
Mean change from baseline in skin hydration (Skin capacitance by Corneometer [a.u.])
Time Frame
after 6 days of treatment
Title
Changes from baseline in objective dermatological evaluation of skin status (erythema, dryness, scaling, fissures, papules, pustules, edema, vesicles, weeping) by dermatologist (min=0, max=3; 3=worse outcome)
Time Frame
after 6 days of treatment
Secondary Outcome Measure Information:
Title
Change from baseline in the scoring of subjective dermatological evaluation via questionnaire (adults) (min=0, max=3; 3=worse outcome)
Time Frame
after 6 days of treatment
Title
Subjective evaluation of itch on Numeric Rating Scale (NRS-11) (min= 0, max=10, 10 = worst imaginable itch)
Time Frame
every day, day 1 until 6 days of treatment
Title
Evaluation of products traits via questionnaire (20 questions with different answers, no scales)
Time Frame
after 6 days of treatment
Title
Safety of BNO 3732 measured by reported Adverse Events
Time Frame
until day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Written Informed Consent of the subject to participate in the study, or, for underaged subjects of the parents/ legal guardians to let their child participate in the study Willingness to actively participate in the study and to come to the scheduled visits or, for underaged subjects, willingness of the parents/ legal guardians to actively support their child's participation in the study and to come to the scheduled visits with their child Female and/or male Children from 6 months to 14 years of age and Adult subjects between 18 and 65 years of age Eczema-prone skin and atopic diathesis, diagnosed by the dermatologist Exclusion Criteria: Female subjects: Pregnancy or lactation Drug addicts, alcoholics AIDS, HIV-positive or infectious hepatitis Conditions which exclude a participation or might influence the test reaction/evaluation Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years Insulin-dependent diabetes mellitus One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases Documented allergies to cosmetic products and/ or ingredients, skin care and/or skin cleansing products Wounds, moles, tattoos, scars, excessive hair growth, etc. at the test area that could influence the investigation Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study Systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac), except for minor pain relief medicine like acetylsalicylic acid or paracetamol within the last 3 days prior to the start of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabrina Laing, Dr.
Organizational Affiliation
proDERM GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
SGS proderm GmbH
City
Schenefeld
ZIP/Postal Code
22869
Country
Germany

12. IPD Sharing Statement

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Assessment of Skin Tolerance and Efficacy of a Cosmetic Product After 5 Days of Use on Subjects With Atopic Dermatitis

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