Trial Outcomes & Findings for A 21 Day Irritation Study in Healthy Volunteers With Diacerein 1% Ointment (NCT NCT03472534)

Last Updated: 2020-02-05

Results Overview

Evaluation of the sum of all subjects' cumulative irritation scores for 21 days at each patch site. 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

46 participants

Primary outcome timeframe

Daily for 21 days

Results posted on

2020-02-05

Participant Flow

This does not apply

Unit of analysis: skin patch test sites

Participant milestones

Participant milestones
Measure	Single Cohort (Healthy Volunteers) Diacerein 1% ointment, vehicle ointment, 0.2% sodium lauryl sulfate (SLS; positive control), and 0.9% saline (negative control) were applied at 4 randomly assigned, adjacent skin sites on the infrascapular area of each subject's back once daily for 21 consecutive days.
Overall Study STARTED	46 184
Overall Study Diacerein 1% Ointment	46 46
Overall Study Vehicle Ointment	46 46
Overall Study 0.2% Sodium Lauryl Sulfate (SLS)	46 46
Overall Study 0.9% Saline	46 46
Overall Study COMPLETED	35 140
Overall Study NOT COMPLETED	11 44

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Cohort (Healthy Volunteers) Diacerein 1% ointment, vehicle ointment, 0.2% sodium lauryl sulfate (SLS; positive control), and 0.9% saline (negative control) were applied at 4 randomly assigned, adjacent skin sites on the infrascapular area of each subject's back once daily for 21 consecutive days.
Overall Study Withdrawal by Subject	9
Overall Study Adverse Event	2

Baseline Characteristics

A 21 Day Irritation Study in Healthy Volunteers With Diacerein 1% Ointment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Cohort (Healthy Volunteers) n=46 Participants Diacerein 1% ointment, vehicle ointment, 0.2% sodium lauryl sulfate (SLS; positive control), and 0.9% saline (negative control) were applied at 4 randomly assigned, adjacent skin sites on the infrascapular area of each subject's back once daily for 21 consecutive days.
Age, Continuous	53 years STANDARD_DEVIATION 13 • n=93 Participants
Sex: Female, Male Female	34 Participants n=93 Participants
Sex: Female, Male Male	12 Participants n=93 Participants
Race (NIH/OMB) Count of Participants · American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Count of Participants · Asian	1 Participants n=93 Participants
Race (NIH/OMB) Count of Participants · Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Count of Participants · Black or African American	27 Participants n=93 Participants
Race (NIH/OMB) Count of Participants · White	18 Participants n=93 Participants
Race (NIH/OMB) Count of Participants · More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Count of Participants · Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	46 participants n=93 Participants

PRIMARY outcome

Timeframe: Daily for 21 days

Population: Per Protocol Population includes all subjects who completed the study with 21 evaluations of irritancy or who discontinued patch sites due to limiting irritation, and was used for analysis of cumulative irritation.

Outcome measures

Outcome measures
Measure	Single Cohort (Healthy Volunteers) n=140 Patch sites Diacerein 1% ointment, vehicle ointment, 0.2% sodium lauryl sulfate (SLS; positive control), and 0.9% saline (negative control) were applied at 4 randomly assigned, adjacent skin sites on the infrascapular area of each subject's back once daily for 21 consecutive days.
Skin Irritation Score Diacerein 1% ointment	0 Normalized cumulative irritation score
Skin Irritation Score Vehicle 1% ointment	0 Normalized cumulative irritation score
Skin Irritation Score 0.2% sodium lauryl sulfate (SLS) (positive control	339 Normalized cumulative irritation score
Skin Irritation Score 0.9% saline (negative control)" Arms/Groups)	15 Normalized cumulative irritation score

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

Phone: 862-286-0400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place