Phase 1
N=61
A 6-Week Study to Evaluate the Photoallergic Potential of Diacerein 1% Ointment in Healthy Volunteers
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03473197 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score — 10; 3; 1; 0 Number of affected skin sites
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Diacerein 1% ointment (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Castle Creek Pharmaceuticals, LLC
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score |
10; 3; 1; 0; 0; 0 | — |
Summary
A study in healthy male and female adult volunteers to determine the potential of diacerein 1% ointment to induce a photoallergic skin reaction using a controlled photopatch testing procedure.
Eligibility Criteria
Key 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 an acceptable form 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 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;
- 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);
- Are taking medication known to cause phototoxic reactions (eg, tetracyclines, thiazides, nonsteroidal anti-inflammatory drugs [NSAIDS]);
- Is using medication which, in the opinion of the Investigator, will interfere with the study results;
- Is unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study;
- Has psoriasis and/or active atopic dermatitis/eczema;
- Had a known sensitivity or allergy to constituents of the 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 drugs(s) with 4 weeks prior to study entry
Data sourced from ClinicalTrials.gov (NCT03473197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.