Clinical Trial On Face Cream In Healthy Male Or Female subjects

A Prospective, Open-Label, Single Arm Study To Evaluate The Safety And Efficacy Of Bakutrol Face Cream For Its Anti-Acne Effect In Otherwise Healthy Male Or Female Volunteers

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/08/044766

Enrollment

Registered

2022-08-22

Start date

Unknown

Completion date

Unknown

Last updated

2023-02-06

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: Bakutrol: Dosage form : Cream Duration: Twice daily (Morning and Evening) Wash the face with gentle clenser and dab dry with clean towel. then apply Bakutol cream gently as a thin layer

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
1.Anti-inflammatory effects of the formulation in patients with facial acne 2.Percentage reduction in total, inflammatory and non-inflammatory lesion count from baseline Timepoint: Day 0 to Day 60	—

Countries

India

Contacts

Public ContactDr Ashok Godavarthi

Radiant research services pvt. Ltd.

ashok@radiantresearch.in9880999297

Outcome results

None listed

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