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This is an open label multi centre study to evaluate the safety and efficacy of anti acne formulation in patients with facial acne.

A prospective open label multi-centre study to evaluate the safety and efficacy of a topical anti-acne formulation in patients with facial acne.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/12/006463
Enrollment
36
Registered
2015-12-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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 Health Condition 2: null- Patients with moderate acne vilgaris

Interventions

Intervention1: Anti acne cream: Topical application of anti acne cream twice a day on the affected area for 60 days after washing their face with face wash. Control Intervention1: NIL: NIL

Sponsors

A Menarini India Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Male and female patients aged 18 to 50 years, with a diagnosis of moderate facial acne vulgaris 2 Facial inflammatory lesion count > 20 and 3 Non inflammatory lesion count of atleast 20-100. 4 Investigators Global Assessment Score of 3.

Exclusion criteria

Exclusion criteria: 1 Patients with 2 nodulocystic lesions, prior topical acne treatment or systemic anti inflammatory agents in past 14 days. 2 Patients on systemic corticosteroids, antibacterial, immunosuppressant drugs or abrading facial procedures in the past 30 days. 3 Patients with other concurrent facial skin disease and patients who are photosensitive or who are likely to engage in activities that involve excessive or prolonged exposure to sunlight. 4 Patients with drug induced acne. 5 Patients with menopausal disorders. 6 Has a history of significant reactions to topical acne treatments, or a known allergy or hypersensitivity to any listed ingredients. 7 Use of oral retinoids within 6 months of Baseline visit.

Design outcomes

Primary

MeasureTime frame
1 Investigators Global Assessment 2 Facial inflammatory and non inflammatory lesion countTimepoint: 1 Investigators Global Assessment 2 Facial inflammatory and non inflammatory lesion count

Secondary

MeasureTime frame
1 Standardized Clinical PhotographsTimepoint: 1 Standardized Clinical Photographs (Baseline and Day 45)

Countries

India

Contacts

Public ContactMr Kiran Vuppala

ClinWorld Provate Limited

kiran@clinworld.org08028397973

Outcome results

None listed

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