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Phase 1 21-Day Evaluation of the Cumulative Irritation Potential of RUT058-60 on Abraded and Non-Abraded Skin Sites
The purpose of this study is to determine the skin irritation potential of RUT058-60 after repetitive patch application to abraded and non-abraded skin of human subjects.
Details
| Lead sponsor | Pulmatrix Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 43 |
| Start date | 2014-07 |
| Completion | 2014-09 |
Conditions
- Irritation/Irritant
Interventions
- Hypochlorous acid solution 106 mg/L
- 0.1% (w/v) Sodium Lauryl Sulfate
- 0.9% Physiological Saline, USP
Primary outcomes
- Cumulative Irritation Score of RUT058-60 Hypochlorous Acid Solution (106 mg/L) on Healthy Human Skin — 21 days
Primary Analysis After a 23-hour ± 1-hour period of exposure, patches were removed, and the sites evaluated and visually scored for irritancy. The procedures will be repeated on the same test sites an additional twenty times. On each day,mean values, sample sizes, ranges, etc., of the irritation scores, for a total of six configurations, were recorded. Grading Scale for Visual Evaluation of Skin Condition: 0= no evidence of irritation, 1= minimal erythema, barely perceptible, 2= definite erythema, readily visible; minimal edema or minimal papular response, 3= erythema and papules, 4= definite edema, 5= erythema, edema, and papules, 6=' vesicular eruption, 7= strong reaction spreading beyond test site Visual observations of 3, 4, or 5 resulted in discontinuance of product application to that site. Observations of 6 or 7 were considered an adverse event and subject discontinued from the study.
Countries
United States