21 Day Cumulative Skin Irritation of RUT058-60
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|ClinicalTrials.gov Identifier: NCT02198963|
Recruitment Status : Completed
First Posted : July 24, 2014
Results First Posted : February 4, 2016
Last Update Posted : February 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Irritation/Irritant||Drug: Hypochlorous acid solution 106 mg/L Drug: 0.1% (w/v) Sodium Lauryl Sulfate Drug: 0.9% Physiological Saline, USP||Phase 1|
This Cumulative Irritation Evaluation is designed to determine the skin irritation potential of RUT058-60, after repetitive patch application to abraded and non-abraded skin of healthy human subjects. Abraded skin will be challenged because the Test Product may be used, in practice, on non-intact skin. The primary research objective in this study is determine the skin irritation potential of RUT058-60. This question will be answered based on the observed results acquired evaluating its application to the abraded and non-abraded skin of at least 30 volunteer subjects, on the test product relative to the control readings.
A sufficient number of subjects will be recruited into the study to ensure 30 subjects, including both males and females, complete the study. Prior to the first application of test materials, designated skin sites will be abraded using the Tape Stripping Procedure. Occlusive patches will be used to apply approximately 0.02 mL of Test Product, Positive Control and Negative Control to abraded and non-abraded sites on the skin in the scapular region of each subject's back. The irritation potential of the test materials will be determined over the course of a 21-day challenge period on at least 30 subjects. A test material will be applied to the same site, abraded and non-abraded, on each day for 21 days. The six skin sites will be evaluated visually prior to each patch application and following the final patch removal.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Phase 1 21-Day Evaluation of the Cumulative Irritation Potential of RUT058-60 on Abraded and Non-Abraded Skin Sites|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||September 2014|
Experimental: Hypochlorous acid Solution 106 mg/L
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.
Drug: Hypochlorous acid solution 106 mg/L
Other Name: RUT058-60
Active Comparator: 0.1% (w/v) Sodium Lauryl Sulfate
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.
Drug: 0.1% (w/v) Sodium Lauryl Sulfate
Other Name: SLS
Placebo Comparator: 0.9% Physiological Saline, USP
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.
Drug: 0.9% Physiological Saline, USP
Other Name: sterile saline
- Cumulative Irritation Score of RUT058-60 Hypochlorous Acid Solution (106 mg/L) on Healthy Human Skin [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198963
|United States, Montana|
|BioScience Laboratories, Inc.|
|Butte, Montana, United States, 59701|
|Principal Investigator:||John Pullman, M.D.||BioScience Laboratories, Inc.|