This is an open label multi centre study to evaluate the safety and efficacy of anti acne formulation in patients with facial acne.
- Conditions
- Health Condition 1: L700- Acne vulgarisHealth Condition 2: null- Patients with moderate acne vilgaris
- Registration Number
- CTRI/2015/12/006463
- Lead Sponsor
- A Menarini India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
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 < 50 both inclusive
3 Non inflammatory lesion count of atleast 20-100.
4 Investigators Global Assessment Score of 3.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method