Trial Outcomes & Findings for A 6-Week Study to Evaluate the Photoallergic Potential of Diacerein 1% Ointment in Healthy Volunteers (NCT NCT03473197)

Last Updated: 2020-02-05

Results Overview

The determination of photosensitization reactions was summarized by frequency counts of the total dermal irritation score during the Challenge Phase. Total Irritation Score is a visual score summing the degree of erythema and edema. Minimum score=0, maximum score=5; higher score=worse outcome

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

61 participants

Primary outcome timeframe

Skin sites evaluated 24, 48, and 72 hours after patch removal and irradiation challenge

Results posted on

2020-02-05

Participant Flow

Unit of analysis: Skin sites

Participant milestones

Participant milestones
Measure	Single Cohort (Healthy Volunteers) During the 3-week Induction Phase, diacerein 1% ointment and vehicle ointment were applied under fully occlusive patch conditions to two randomly assigned skin sites on the infrascapular region of the back twice each week for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. Following a rest period, during the Challenge Phase, the study products were applied to two naive sites once for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. A Re-Challenge was to be performed if a response observed during the Challenge Phase indicated photosensitization.
Overall Study STARTED	61 255
Overall Study Diacerein 1% Ointment Irradiated	51 51
Overall Study Vehicle Ointment Irradiated	51 51
Overall Study Diacerein 1% Ointment Non-irradiated	51 51
Overall Study Vehicle Ointment Non-irradiated	51 51
Overall Study Untreated Irradiated	51 51
Overall Study COMPLETED	51 255
Overall Study NOT COMPLETED	10 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Cohort (Healthy Volunteers) During the 3-week Induction Phase, diacerein 1% ointment and vehicle ointment were applied under fully occlusive patch conditions to two randomly assigned skin sites on the infrascapular region of the back twice each week for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. Following a rest period, during the Challenge Phase, the study products were applied to two naive sites once for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. A Re-Challenge was to be performed if a response observed during the Challenge Phase indicated photosensitization.
Overall Study Adverse Event	4
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	5

Baseline Characteristics

A 6-Week Study to Evaluate the Photoallergic Potential of Diacerein 1% Ointment in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Cohort (Healthy Volunteers) n=61 Participants During the 3-week Induction Phase, diacerein 1% ointment and vehicle ointment were applied under fully occlusive patch conditions to two randomly assigned skin sites on the infrascapular region of the back twice each week for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. Following a rest period, during the Challenge Phase, the study products were applied to two naive sites once for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. A Re-Challenge was to be performed if a response observed during the Challenge Phase indicated photosensitization.
Age, Continuous	52.0 years STANDARD_DEVIATION 14.46 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 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	0 Participants n=5 Participants
Race (NIH/OMB) White	61 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
Region of Enrollment United States	61 participants n=5 Participants

PRIMARY outcome

Timeframe: Skin sites evaluated 24, 48, and 72 hours after patch removal and irradiation challenge

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

Outcome measures

Outcome measures
Measure	Single Cohort (Healthy Volunteers) n=255 skin sites During the 3-week Induction Phase, diacerein 1% ointment and vehicle ointment were applied under fully occlusive patch conditions to two randomly assigned skin sites on the infrascapular region of the back twice each week for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. Following a rest period, during the Challenge Phase, the study products were applied to two naive sites once for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. A Re-Challenge was to be performed if a response observed during the Challenge Phase indicated photosensitization.
Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score Diacerein irradiated max score 1 at 24 hrs	10 Number of affected skin sites
Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score Diacerein irradiated max score 1 at 48 hrs	3 Number of affected skin sites
Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score Diacerein irradiated max score 1 at 72 hrs	1 Number of affected skin sites
Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score Diacerein non-irradiated max score 1 at 24 hrs	0 Number of affected skin sites
Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score Diacerein non-irradiated max score 1 at 48 hrs	0 Number of affected skin sites
Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score Diacerein non-irradiated max score 1 at 72 hrs	0 Number of affected skin sites
Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score Vehicle irradiated max score 1 at 24 hrs	10 Number of affected skin sites
Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score Vehicle irradiated max score 1 at 48 hrs	3 Number of affected skin sites
Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score Vehicle irradiated max score 1 at 72 hrs	1 Number of affected skin sites
Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score Vehicle non-irradiated max score 1 at 24 hrs	0 Number of affected skin sites
Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score Vehicle non-irradiated max score 1 at 48 hrs	0 Number of affected skin sites
Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score Vehicle non-irradiated max score 1 at 72 hrs	0 Number of affected skin sites
Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score Untreated irradiated max score 1 at 24 hrs	16 Number of affected skin sites
Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score Untreated irradiated max score 1 at 48 hrs	5 Number of affected skin sites
Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score Untreated irradiated max score 1 at 72 hrs	1 Number of affected skin sites

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

Castle Creek Pharmaceuticals, LLC

Phone: 862 286 0400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place