Clinical Trial On Face Cream In Healthy Male Or Female subjects

Phase 3

Completed

• Conditions: Health Condition 1: L700- Acne vulgaris

• Registration Number: CTRI/2022/08/044766
• Lead Sponsor: Viridis Bioharma Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-01-23
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1.Male and female patients aged 18 to 35 years

2.Diagnosis of moderate facial acne vulgaris

3.Phototype I II III or IV according to Fitzpatrick classification

4.Facial inflammatory lesion count grater than 20 and

5.Non inflammatory lesions count of at least 20-100

6.Investigators Global Assessment score 3

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 abradant 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 retinoid within 6 months of Baseline visit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.%Change from baseline in the inflammatory lesion count <br/ ><br>2.%Change from baseline in the non-inflammatory lesion count <br/ ><br>3.The proportion of success according to the dichotomized IGA <br/ ><br>4.% Change in the microbial load (Acne specific) <br/ ><br>5.%Change in the acne as assessed through video-dermoscopy from baseline to last visit <br/ ><br>Timepoint: Day 0 to Day 60

Secondary Outcome Measures

Name	Time	Method
1.Anti-inflammatory effects of the formulation in patients with facial acne <br/ ><br>2.Percentage reduction in total, inflammatory and non-inflammatory lesion count from baseline <br/ ><br>Timepoint: Day 0 to Day 60