Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02198963 | 21 Day Cumulative Skin Irritation of RUT058-60 | PHASE1 | COMPLETED | 43 | — | — | Jul 1, 2014 | Sep 1, 2014 | Feb 4, 2016 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Hypochlorous acid Solution 106 mg/L | EXPERIMENTAL | Occlusive patches will be used to apply approximately 0.02 mL of the Test Product RUT058-60 to abraded and non-abraded sites on the skin in the scapular region of each subject's back. |
| 0.1% (w/v) Sodium Lauryl Sulfate | ACTIVE_COMPARATOR | Occlusive patches will be used to apply approximately 0.02 mL of the Positive Control (0.1% Sodium Lauryl Sulfate) to abraded and non-abraded sites on the skin in the scapular region of each subject's back, once daily for 21 days. |
| 0.9% Physiological Saline, USP | PLACEBO_COMPARATOR | Occlusive patches will be used to apply approximately 0.02 mL of the Negative Control (0.9% Physiological Saline, USP) to abraded and non-abraded sites on the skin in the scapular region of each subject's back, once daily for 21 days. |
| Name | Type | Description |
|---|---|---|
| Hypochlorous acid solution 106 mg/L | DRUG | test product |
| 0.1% (w/v) Sodium Lauryl Sulfate | DRUG | positive control |
| 0.9% Physiological Saline, USP | DRUG | negative control |
Inclusion Criteria: * Subjects may be of either sex, at least 18 years of age and of any race * Subjects must be free of tattoos, sunburn, dermatoses, cuts, lesions, or other disorders on the parascapular skin of the back * Subjects must be in good general health, as evidenced by the Subject Confid...