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A study to compare two drugs benzoyl peroxide and azelaic acid for improvement in symptoms and skin tolerability

A comparative study of efficacy and tolerability of topical benzoyl peroxide versus topical azelaic acid in patients with mild to moderate acne vulgaris at a tertiary care centre

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041085
Enrollment
120
Registered
2022-03-14
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: L700- Acne vulgaris

Interventions

Intervention1: Topical Azelaic acid 10% cream: Duration: 12 weeks Patients are advised to wash their face and dry it well before applying. 1 fingertip unit (approximately 0.5 gram) of the study drug

Sponsors

Raghav M V
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex willing to give informed consent/ assent and willing to come for follow up Patients aged 12-60 years Patients with mild to moderate acne on face above jaw line (Indian Acne Alliance Grading) (Annexure 4) Women with negative urine pregnancy test result and agree to use an effective form of contraception for the duration of study (12 weeks)

Exclusion criteria

Exclusion criteria: Patients with severe acne on face (Indian Acne Alliance Grading) (Annexure 4) Patients with acne on chest and back Other variants of acne; chloracne, oil acne, topical acne, mechanical acne, severe variants like acne conglobate and acne fulminans drug induced acne Patients on any oral or topical medications for acne If follow up disease progresses and necessitates systemic therapy Pregnant and lactating mother Patients with known hypersensitivity to any of the components of the drug

Design outcomes

Primary

MeasureTime frame
Efficacy assessment ââ?¬â?? the efficacy of the drugs will be evaluated at 4, 8 and at 12 weeks follow up by spot counting of acne lesions on face by the dermatologist and graded according to IGA for Severity of acne. At baseline, the total number of lesions on face is taken as 100%. Any reduction in the number of acne lesions at the follow ups is compared with baseline and expressed as percentage of improvement and graded. Timepoint: 0,4,8,12 weeks—

Secondary

MeasureTime frame
Tolerability parameters ââ?¬â?? each of the parameters- scaling, erythema, burning, itching will be assessed and graded by the dermatologist at 4, 8 and 12 weeks follow upTimepoint: 0,4,8,12 weeks—

Countries

India

Contacts

Public ContactRaghav M V

Bangalore Medical College and research institute

raghav.m.ram@gmail.com8105702966

Outcome results

None listed

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