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.

Phase 3

Not yet recruiting

Conditions: Diseases of the skin and subcutaneous tissue,

Registration Number: CTRI/2023/08/056777

Lead Sponsor: Kusum Healthcare Private Limited

Brief Summary: The primary purpose of this study is to evaluate the bioequivalence (Clinical equivalence) of test formulation Azelaic acid 15% Gel of Kusum Healthcare Pvt. Ltd., India With Skinoren 15 % Gel (Azelaic acid) Leo Pharma, EU among Subjects with mild to moderate papular-pustular acne of the facial area or facial rosacea.

This is a 12 week study and the primary end point of this study will be assessed through 12 weeks. This will allow for assessment of efficacy at a time point for which efficacy data of the approved product is available. The placebo-controlled study design was chosen to demonstrate the efficacy of the test product in adult subjects with mild to moderate papular-pustular acne of the facial area or facial rosacea to placebo. Due to the nature of rosacea and the outcome measures for the primary and the secondary endpoints used, a placebo arm is necessary for reliable results on efficacy and safety.

The reference product, Skinoren Gel is already available in the market from 1989 and its safety and efficacy is profile is well established. Additonally, the inclusion of a placebo group is in accordance with health authority guidelines. A placebo control arm is recommended to demonstrate that the test product and reference product are active and as a parameter that the study is sufficiently sensitive to detect differences between products.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 330

Inclusion Criteria

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.

Exclusion Criteria

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	To Evaluate the bioequivalence (Clinical \| equivalence) of test formulation Azelaic \| acid 15% Gel at week 12
acid 15% Gel at week 12	To Evaluate the bioequivalence (Clinical \| equivalence) of test formulation Azelaic \| acid 15% Gel at week 12

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety of Azelaic acid 15% Gel over 12 weeks

Trial Locations

Locations (1): Madurai Medical College and Govt. Rajaji Hospital,
🇮🇳
Madurai, TAMIL NADU, India
Madurai Medical College and Govt. Rajaji Hospital,
🇮🇳Madurai, TAMIL NADU, India
Dr R Kothandaramasamy
Principal investigator
9789328238
ranjith@leszarians.com