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

NCT05807113 | Completed

• 1 other identifier: CS02AC-ICBD
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Diathesis; Eczema-prone Skin

Outcome Measures

Primary Outcomes (4)

• Mean change from baseline in transepidermal water loss (g/m2h)

  after 6 days of treatment

• Mean change from baseline in skin redness by Chromameter

  after 6 days of treatment

• Mean change from baseline in skin hydration (Skin capacitance by Corneometer [a.u.])

  after 6 days of treatment

• 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)

  after 6 days of treatment

Secondary Outcomes (4)

• Change from baseline in the scoring of subjective dermatological evaluation via questionnaire (adults) (min=0, max=3; 3=worse outcome)

  after 6 days of treatment

• Subjective evaluation of itch on Numeric Rating Scale (NRS-11) (min= 0, max=10, 10 = worst imaginable itch)

  every day, day 1 until 6 days of treatment

• Evaluation of products traits via questionnaire (20 questions with different answers, no scales)

  after 6 days of treatment

• Safety of BNO 3732 measured by reported Adverse Events

  until day 29

Study Arms (2)

Atopi intensive care BNO 3731 for topical use

EXPERIMENTAL

Other: Atopi intensive care BNO 3731

Benchmark skin care product for topical use

ACTIVE COMPARATOR

Other: Benchmark product

Interventions

Atopi intensive care BNO 3731 OTHER

Crem twice daily

Atopi intensive care BNO 3731 for topical use

Benchmark product OTHER

Crem twice daily

Benchmark skin care product for topical use

Eligibility Criteria

• Age: 6 Months - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Bionorica SE: lead

Study Sites (1)

SGS proderm GmbH

Schenefeld, 22869, Germany

Location

Study Officials

• Sabrina Laing, Dr.

  proDERM GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: intra-individual comparison

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: April 11, 2023
• Study Start: February 15, 2022
• Primary Completion: February 22, 2022
• Study Completion: February 22, 2022
• Last Updated: April 11, 2023

Record last verified: 2023-02

Locations

DE (1)