Skin Efficacy and Tolerability of a Cosmetic Product Combination Over 3 Months in Subjects With Atopic Eczema

NCT05790083 | Unknown

• 1 other identifier: AtoCare-OS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this exploratory study is to investigate the short- and long-term efficacy and tolerability of a cosmetic product combination consisting of a body lotion and an intensive care product in subjects with atopic eczema over 3 months of use. Efficacy is assessed by instrumental measurements of skin condition (sub-panel), clinical examinations, and questionnaires.

Conditions

Atopic Dermatitis; Eczema-Prone Skin

Outcome Measures

Primary Outcomes (4)

• Change 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 = worst outcome) to Day 29, Day 57 and Day 85

  85 days of treatment

• Change from baseline in Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM, (min = 0, max = 3; 3 = worst outcome) to Day 29, Day 57 and Day 85

  85 days of treatment

• Change from baseline in Recap of atopic eczema (RECAP, min = 0, max = 4; 4 = worst outcome) to Day 29, Day 57 and Day 85

  85 days of treatment

• Change from baseline in Dermatology Life Quality Index (DLQI, 10 closed questions with varying scales) to Day 29, Day 57 and Day 85

  85 days of treatment

Secondary Outcomes (5)

• Change from baseline in the scoring of subjective dermatological evaluation via questionnaire (adults) (no scales) to Day 29, Day 57 and Day 85

  85 days of treatment

• Evaluation of product traits via questionnaire (7 questions with different answers, no scales) on day 1 and after 29, 57, 85 days

  85 days of treatment

• Sub-group: mean change from baseline in transepidermal water loss (g/m2h), Lipid contents (ng/133mm²) and Morphological analysis (length of lipid lamellae, nm/1.000nm²) to Day 85

  85 days of treatment

• Safety of BNO 3732 and BNO 3731 measured by reported Adverse Events to Day 85

  85 days of treatment

• Subject diary (frequency of flare-ups, required physician visits, required drug administration/use of cortisone, well-being)

  85 days of treatment

Study Arms (1)

Body Lotion BNO 3732 + Intensive Care BNO 3731

EXPERIMENTAL

Other: Body Lotion and Intensive Care

Interventions

Body Lotion and Intensive Care OTHER

Body Lotion, applied twice daily on whole body, for 3 months. Intensive Care, applied as needed on affected body areas.

Body Lotion BNO 3732 + Intensive Care BNO 3731

Eligibility Criteria

• Age: 2 Years - 75 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 2 to 17 years of age and adult subjects between 18 and 75 years of age
• Eczema-prone skin and atopic dermatitis, diagnosed by the dermatologist

You may not qualify if:

• Female subjects (only of childbearing age): Pregnancy or lactation
• Drug addicts, alcoholics (only adults)
• 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 as well as to ingredients of the test products
• Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
• Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids, cyclosporine, dupilumab) 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, ibuprofen), except for minor pain relief medicine like acetylsalicylic acid or paracetamol within the last 3 days prior to the start of the study
• Any topical medicinal products (e.g. topical corticosteroids, calcineurin inhibitors) at the test area within the last 5 days prior to the start of the study
• Any topical medication at the test area throughout the entire course of the study (except the medication normally used for treatment of atopic eczema)

Sponsors & Collaborators

• Bionorica SE: lead

Study Sites (1)

SGS proderm GmbH

Schenefeld, 22869, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Critical Care

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Katrin Unbereit, Dr.

  proDERM GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Trade name of products was masked
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 29, 2023
• Study Start: January 3, 2023
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

DE (1)