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)
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): NCT03472534
|United States, New Jersey|
|Fair Lawn, New Jersey, United States, 07410|