Verification test of moisturizer Human Adipose Derived Stem Cell Conditioned Media Extract for patients with atopic dermatitis

UMIN ID: UMIN000054448

Registered date:21/05/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Atopic dermatitis
• Date of first enrollment: 2024/01/11
• Target sample size: 25
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Test product A is applied to the inner right forearm and test product B is applied to the inner left forearm twice daily (after waking up and bathing) for six weeks, two pushes each.
Test product B is applied to the inner right forearm and test product A is applied to the inner left forearm twice daily (after waking up and bathing) for six weeks, two pushes each.

Outcome(s)

• Primary Outcome: Stratum corneum moisture content
• Secondary Outcome: Skin observation by a dermatologist (at screening, start date, 3 weeks after start date, and 6 weeks after start date) - Physician's observation: dryness, desquamation, erythema, papules, scars - Subjective symptoms: itching, irritation Instrumental Measurement (at start date, 3 weeks after start date, and 6 weeks after start date) - Transepidermal water loss - Roughness, smoothness, and scale Others (at start date, 3 weeks after start date, and 6 weeks after start date) - Questionnaire on the usability of the subject diary and test product, etc.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 60years-old
• Gender: Female
• Exclude criteria: Exclude those who meet at least one of the following conditions: (1) Patients with atopic dermatitis of moderate severity or higher (skin rash with severe inflammation such as lesions with erythema, papule, erosion, infiltration, lichenization, etc.) covering less than 10% of body surface area). (2) Patients taking oral steroids, antihistamines, antiallergic agents, immunosuppressive agents, or tranquilizers. (3) Patients who have had serious allergic symptoms due to the use of topical medicines, cosmetics, quasi-drugs, or other products in the past. (4) Those who have a serious disease and are considered inappropriate for inclusion. (5) Those who are under treatment or being outpatients due to illness (excluding the common cold and dental disease). (6) Those who have a family member who works for a pharmaceutical or cosmetics company. (7) Those who are participating or have participated within four weeks in other clinical trials or investigations involving the use of cosmetics, quasi-drugs, or food products. (8) Any other person who is judged to be inappropriate by the investigator.

Related Information

• Primary Sponsor: TeleBio Inc.
• Source(s) of Monetary Support: TeleBio Inc.