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A Clinical Trial to Determine the Therapeutic Benefit of an Investigational Over-The-Counter Cream on Dry, Itchy Skin of Adults and Children With Atopic Dermatitis.
The objective of this 1 week trial is to evaluate the efficacy of an over-the-counter (OTC) 1% colloidal oatmeal skin protectant cream in adults and children with mild to moderate AD.
Details
| Lead sponsor | Johnson & Johnson Consumer Inc. (J&JCI) |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 53 |
| Start date | 2016-02 |
| Completion | 2016-04 |
Conditions
- Atopic Dermatitis
Interventions
- EpiCeram Skin Barrier Emulsion
- Experimental Product 1% Colloidal Oatmeal Balm
Primary outcomes
- Change From Baseline in the Itch Assessment Score Immediately Following Treatment — Baseline to immediately following treatment
The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable. - Change From Baseline in the Itch Assessment Score 1 Hour After Treatment — Baseline to one hour after treatment
The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable. - Change From Baseline in the Itch Assessment Score 2 Hours After Treatment — Baseline to two hours after treatment
The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable. - Change From Baseline in the Itch Assessment Score 3 Hours After Treatment — Baseline to three hours after treatment
The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable. - Change From Baseline in the Itch Assessment Score 4 Hours After Treatment — Baseline to four hours after treatment
The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable. - Change From Baseline in the Itch Assessment Score 5 Hours After Treatment — Baseline to five hours after treatment
The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Countries
United States