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Effectiveness and safety of a fixed dosed combination of adapalene and clindamycin in the treatment of acne vulgaris.

Comparison of the effectiveness and safety of two topical delivery systems of a fixed dosed combination of adapalene and clindamycin in the treatment of acne vulgaris, a double arm, open label, observational study - Adapalene 0.1 % and clindamycin 1 % combination

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013109
Enrollment
55
Registered
2018-04-09
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: null- Acne Vulgaris Health Condition 2: L088- Other specified local infections of the skin and subcutaneous tissue

Interventions

None listed

Sponsors

Investigator Initiated Study
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with acne of mild to moderate as per the Combined Acne Severity Classification.8 a. Mild acne: fewer than 20 comedones, or fewer than 15 inflammatory lesions or a total lesion count lower than 30 b. Moderate acne: 20-100 comedones, or 15-50 inflammatory lesions or a total lesion count of 30-125 c. Severe acne: more than 5 cysts, or comedone count greater than 100, or a total inflammatory count greater than 50, or a total lesion count greater than 125 2. Male and female patients aged between 18 to 30 years. 3. Subjects willing to comply with study visits and procedure 4. Patients taking certain topical and systemic treatments required to undergo 01 month washout periods before they can enter the study.

Exclusion criteria

Exclusion criteria: 1. Patients not willing to sign consent form 2. Who have a diagnosed hormonal or endocrine cause for acne 3. Acne conglobata, acne fulminans, secondary acne, severe acne, or other dermatologic conditions requiring systemic treatment. 4. Women are to be excluded if they are pregnant, planning a pregnancy or nursing 5. Patients having any contraindication to clindamycin or adapalene 6. Men with beards are excluded if these are likely to cause interference with study assessments 7. Any significant medical condition which may interfere with the patients optimal participation in the study as per Investigators opinion

Design outcomes

Primary

MeasureTime frame
To compare the effectiveness of hydro swelling polymer delivery system with microsphere delivery system of a combination of adapalene 0.1% + clindamycin 1% in patients with acne.Timepoint: day 0, day 28, day 56

Secondary

MeasureTime frame
To compare the safety of hydro swelling polymer delivery system with microsphere delivery system of a combination of adapalene 0.1% & clindamycin 1% in patients with acneTimepoint: Day 0, day 28, Day 56

Countries

India

Contacts

Public ContactDr Shrilata S Trasi
shrilata_trasi@hotmail.com022-26051858

Outcome results

None listed

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