Trial Outcomes & Findings for A Study of Sensitizing Potential of Diacerein 1% Ointment in Healthy Subjects (NCT NCT03472547)

NCT ID: NCT03472547

Last Updated: 2019-10-21

Results Overview

The determination of dermal sensitization potential was based on the recurrence of a cutaneous response at re-challenge that was equivalent or more severe than the cumulative irritation score observed during the challenge period. Cumulative irritation score is a visual score rating the degree of erythema, edema, and other signs of cutaneous irritation: Minimum = 0; Maximum = 6; higher score is worse outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 234 participants
• Primary outcome timeframe: 56 days
• Results posted on: 2019-10-21

Participant Flow

Unit of analysis: skin patch test sites

Participant milestones

Measure	Single Cohort (Healthy Volunteers) All subjects were exposed to diacerein 1% ointment, vehicle ointment, and 0.9% saline (negative control) at 3 randomly assigned, adjacent skin sites on the infrascapular area of the back 3 times weekly for 3 weeks (9 applications) during the Induction Phase, and one time during the Challenge Phase (10 times in total).
Overall Study STARTED	234 702
Overall Study COMPLETED	204 612
Overall Study NOT COMPLETED	30 90

Reasons for withdrawal

Measure	Single Cohort (Healthy Volunteers) All subjects were exposed to diacerein 1% ointment, vehicle ointment, and 0.9% saline (negative control) at 3 randomly assigned, adjacent skin sites on the infrascapular area of the back 3 times weekly for 3 weeks (9 applications) during the Induction Phase, and one time during the Challenge Phase (10 times in total).
Overall Study Withdrawal by Subject	30

Baseline Characteristics

A Study of Sensitizing Potential of Diacerein 1% Ointment in Healthy Subjects

Baseline characteristics by cohort

Measure	Single Cohort (Healthy Volunteers) n=234 Participants All subjects were exposed to diacerein 1% ointment, vehicle ointment, and 0.9% saline (negative control) at 3 randomly assigned, adjacent skin sites on the infrascapular area of the back 3 times weekly for 3 weeks (9 applications) during the Induction Phase, and one time during the Challenge Phase (10 times in total).
Age, Continuous	52.1 years STANDARD_DEVIATION 11.74 • n=5 Participants
Sex: Female, Male Female	176 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	214 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	166 Participants n=5 Participants
Race (NIH/OMB) White	68 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 56 days

Population: The evaluation of sensitization was based on all subjects who completed the Challenge Phase of the study.

The determination of dermal sensitization potential was based on the recurrence of a cutaneous response at re-challenge that was equivalent or more severe than the cumulative irritation score observed during the challenge period.

Cumulative irritation score is a visual score rating the degree of erythema, edema, and other signs of cutaneous irritation: Minimum = 0; Maximum = 6; higher score is worse outcome.

Outcome measures

Measure	Observed Sensitization n=204 Participants All subjects were exposed to diacerein 1% ointment, vehicle ointment, and 0.9% saline (negative control) at 3 randomly assigned, adjacent skin sites on the infrascapular area of the back 3 times weekly for 3 weeks (9 applications) during the Induction Phase, and one time during the Challenge Phase (10 times in total).
Observed Sensitization Diacerein 1% ointment	0 Participants with Observed Sensitization
Observed Sensitization vehicle ointment	0 Participants with Observed Sensitization
Observed Sensitization 0.9% saline (negative control)	0 Participants with Observed Sensitization

Adverse Events

Single Cohort (Healthy Volunteers)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mary Spellman; Chief Medical Officer

Castle Creek Pharmaceuticals, LLC

Phone: 862 286 0400

Email: mspellman@castlecreekpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place