A 4-Day Study to Evaluate the Photoxicity of Diacerein 1% Topical Ointment in Healthy Volunteers

Phase 1

Completed

Brief Summary: This study was designed to assess the phototoxic potential of diacerein 1% ointment when application is followed by light exposure.

Detailed Description: This was a single-center, randomized, within-subject comparison of diacerein 1% ointment and vehicle ointment applied to 2 sites on opposite sides of the the infrascapular area of the back under occlusive patch conditions for approximately 24 (±2) hours. Product was applied according to the randomization scheme in an amount of 0.2 mL, once during the study.

Patches were removed and 1 of the skin sites for each product was irradiated and 1 remained non-irradiated. The irradiated and non-irradiated sites were compared with each other and with an untreated irradiated control site.

Recruitment & Eligibility

Inclusion Criteria

Is a healthy male or female (to be confirmed by medical history);
Is 18 years of age or older;
In the case of a female of childbearing potential, is using two acceptable forms of birth control;
In the case of a female of childbearing potential, has a negative urine pregnancy test (UPT) at Day 1 and are willing to submit to a UPT at the end of study (EOS);
Is free of any systemic or dermatological disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of adverse events (AEs);
Is of any Fitzpatrick Skin Type or race, providing the skin pigmentation will allow discernment of erythema

Key

Exclusion Criteria

Has a history of photosensitivity or photoallergy;
Has any visible skin disease at the application site which, in the opinion of the Investigator, will interfere with the evaluation of the test site reaction;
Is using systemic/topical corticosteroids within 3 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;
Is not willing to refrain from using systemic/topical anti-inflammatory analgesics such as aspirin (occasional use of acetaminophen will be permitted);
Is taking medication known to cause phototoxic reactions (eg, tetracyclines, thiazides, nonsteroidal anti-inflammatory drugs [NSAIDs]);
Has psoriasis and/or active atopic dermatitis/eczema;
Has known sensitivity or allergy to constituents of materials being evaluated including diacerein, mineral oil, petrolatum, cetyl alcohol, D&C Yellow #10 and/or ethyl paraben;
Has damaged skin in or around the test sites, including sunburn, excessively deep tans,uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
Has received treatment for any type of internal cancer within 5 years prior to study entry;
Has any known sensitivity to adhesives; and/or
Has received any investigational drug(s) within 4 weeks prior to study entry

Arm && Interventions

Group	Intervention	Description
Single Cohort (Healthy Volunteers)	Diacerein 1% ointment	Single cohort received diacerein 1% ointment

Primary Outcome Measures

Name	Time	Method
Observed Phototoxicity	Days 3 and 4 (24 and 48 hours post site irradiation procedure)	The mean of the total irritation scores 24 and 48 hours post the site irradiation procedure. ( i.e. Day 3 and 4) Total Irritation Score is a visual score summing the degree of erythema and edema. Minimum score= 0; Maximum score = 5; higher score = worse outcome.

Secondary Outcome Measures