A 21-Day Study to Evaluate the Skin Irritation Potential of CCP-020 (Diacerein 1%) Topical Ointment in Healthy Subjects Using a Cumulative Irritant Patch Test Design
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|ClinicalTrials.gov Identifier: NCT03472534|
Recruitment Status : Completed
First Posted : March 21, 2018
Last Update Posted : March 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Diacerein 1% topical ointment and Vehicle||Phase 1|
This is a clinical study in-humans treated with CCP-020 (Diacerein 1%) topical ointment intended to determine the cumulative irritation potential of CCP-020 (Diacerein 1%) topical ointment treatment on normal human skin in healthy volunteers using a cumulative irritancy patch test (CIPT) design.
Substances that come into contact with human skin need to be evaluated for their propensity to irritate with a reproducible, standardized, quantitative patch evaluation procedure that demonstrates the study material can be applied safely to human skin without significant risk of adverse reactions.
Cumulative irritancy patch evaluation is a modified primary irritancy test, which can detect irritants that require multiple applications to cause a skin reaction. These reactions are due to direct damage to the epidermal cells and no immunologic (allergic) mechanism is involved. This procedure may detect so-called "fatiguing substances," which are mild irritants that cause more strongly positive reactions with successive multiple skin exposure.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of CCP-020 (Diacerein 1%) Topical Ointment in Healthy Subjects Using a Cumulative Irritant Patch Test Design|
|Actual Study Start Date :||January 9, 2018|
|Actual Primary Completion Date :||January 30, 2018|
|Actual Study Completion Date :||January 30, 2018|
|Experimental: Cohort 1 (Healthy Volunteers)||
Drug: Diacerein 1% topical ointment and Vehicle
CCP-020 (Diacerein 1%) topical ointment, approximately 0.2 mL, applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks Vehicle, approximately 0.2 mL, applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks
Other Name: CCP-020
- Skin irritation [ Time Frame: Daily for 21 days ]Determine the potential of CCP-020 (Diacerein 1%) topical ointment to cause skin irritation after repeated topical application to the healthy skin of humans under controlled conditions using local tolerability assessment scales.
- Adverse Events [ Time Frame: Daily for 21 days + 30 days after last product administration ]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472534
|United States, New Jersey|
|Fair Lawn, New Jersey, United States, 07410|