A Double-Blind, Randomized, Placebo-controlled, Multicenter study of Azelaic acid 15% Gel fortreatment of mild to moderate papular-pustular acne of the facial area or facial rosacea.
- Conditions
- Health Condition 1: L00-L99- Diseases of the skin and subcutaneous tissue
- Registration Number
- CTRI/2023/08/056777
- Lead Sponsor
- Kusum Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Male or non-pregnant female aged ? 18 years with a clinical
diagnosis of mild
to moderate papular-pustular acne of the
facial area OR facial rosacea
Subject willing to minimize
external factors that might trigger acne/rosacea
flare- ups (e.g.,
spicy foods, thermally hot foods and drinks, hot environments,
prolonged sun exposure, strong winds and alcoholic beverages
Subject must be in general good health and free from any clinically
significant
disease other than acne/rosacea, that might interfere
with the study
Willing to provide written informed consent for
participation in the study and
adhere to the protocol
requirements
Subjects who agree to return for follow-up visits
Pregnant or lactating or planning to become pregnant during the
study period
Presence of any skin condition on the face that would interfere with
the
diagnosis or assessment of acne/rosacea
Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that
would
interfere with diagnosis or assessment of acne/rosacea
History of hypersensitivity or allergy to study drugs or any other
component
of the formulation
Use within 6 months prior to Baseline of oral retinoids or therapeutic
vitamin
A supplements of greater than 10,000 units/day
Use for less than 3 months prior to Baseline of estrogens or oral
contraceptives;
use of such therapy must remain constant throughout the study
Use within 2 weeks prior to baseline of
1) topical corticosteroids,
2) topical antibiotics or
3) topical medications for acne/rosacea (e.g., metronidazole, azelaic
acid)
Subjects with moderate or severe rhinophyma, dense telangiectases,
or plaquelike
facial edema
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To Evaluate the bioequivalence (Clinical equivalence) of test formulation Azelaic <br/ ><br>acid 15% Gel at week 12Timepoint: To Evaluate the bioequivalence (Clinical <br/ ><br>equivalence) of test formulation Azelaic <br/ ><br>acid 15% Gel at week 12
- Secondary Outcome Measures
Name Time Method To evaluate the safety of Azelaic acid 15% Gel over 12 weeks <br/ ><br>Timepoint: Week 12