A 6-Week Study to Evaluate Photoallergic Skin Reaction of CCP-020 (Diacerein 1%) in Healthy Subjects
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/10/2019 |
Start Date: | January 8, 2018 |
End Date: | March 9, 2018 |
A 6-Week, Randomized Study to Evaluate the Potential of CCP-020 (Diacerein 1%) Topical Ointment to Induce a Photoallergic Skin Reaction in Healthy Subjects, Using a Controlled Photopatch Test Design
A study in healthy male and female adult volunteers to determine the potential of CCP-020
(Diacerein 1%) Topical Ointment to induce a photoallergic skin reaction using a controlled
photopatch testing procedure.
(Diacerein 1%) Topical Ointment to induce a photoallergic skin reaction using a controlled
photopatch testing procedure.
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 (oral/implant/injectable/transdermal contraceptives, intrauterine
device, condom with spermicide, diaphragm with spermicide, abstinence, partner's
vasectomy, tubal ligation). Abstinence or vasectomies are acceptable if the female
subject agrees to implement one of the other acceptable methods of birth control if
her lifestyle/partner changes;
- 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;
- Has uniformly-colored skin on the lower thoracic area of the back which will allow
discernment of erythema, and has Fitzpatrick Skin Types I, II, or III
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 (81 mg daily aspirin will be allowed), Aleve, Motrin, Advil, or Nuprin
for 72 hours prior to and during the study (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 (e.g. anti-inflammatory medications, antipsychotics, anticonvulsants
with potential pain relief effects, immunomodulatory medications, and others);
- 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;
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