A Double-Blind, Randomized, Placebo-controlled, Multicenter study of Azelaic acid 15% Gel for treatment of mild to moderate papular-pustular acne of the facial area or facial rosacea.

A Double-Blind, Randomized, Parallel Group, Placebo-controlled, Multicenter study 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. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056777

Enrollment

330

Registered

2023-08-22

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L00-L99- Diseases of the skin and subcutaneous tissue

Interventions

Intervention1: Azelaic acid: 15 % Gel, applied twice a day morning and evening for 12 weeks, Local application Control Intervention1: Skinoren 15 % Gel (Azelaic acid): 15 % Gel, applied twice a day mo

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
To Evaluate the bioequivalence (Clinical equivalence) of test formulation Azelaic acid 15% Gel at week 12Timepoint: To Evaluate the bioequivalence (Clinical equivalence) of test formulation Azelaic acid 15% Gel at week 12	—

Secondary

Measure	Time frame
To evaluate the safety of Azelaic acid 15% Gel over 12 weeks Timepoint: Week 12	—

Countries

India

Contacts

Public ContactMr Hari Emmadi

Vayam Research Solutions Limited

hari.e@vayamresearch.net9703089558

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026