A 21-Day Study to Evaluate the Skin Irritation Potential of CCP-020 (Diacerein 1%) Topical Ointment in Healthy Subjects Using a Cumulative Irritant Patch Test Design

This is a clinical study in-humans treated with CCP-020 (Diacerein 1%) topical ointment
intended to determine the cumulative irritation potential of CCP-020 (Diacerein 1%) topical
ointment treatment on normal human skin in healthy volunteers using a cumulative irritancy
patch test (CIPT) design.

Substances that come into contact with human skin need to be evaluated for their propensity
to irritate with a reproducible, standardized, quantitative patch evaluation procedure that
demonstrates the study material can be applied safely to human skin without significant risk
of adverse reactions.

Cumulative irritancy patch evaluation is a modified primary irritancy test, which can detect
irritants that require multiple applications to cause a skin reaction. These reactions are
due to direct damage to the epidermal cells and no immunologic (allergic) mechanism is
involved. This procedure may detect so-called "fatiguing substances," which are mild
irritants that cause more strongly positive reactions with successive multiple skin exposure.

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 (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 two 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) on Day 1 prior to randomization 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

Exclusion Criteria:

- 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);

- 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;