A clinical study to evaluate and compare the effects of three drug formulations, Tazarotene microsphere cream, Differin gel and Tazorac cream when applied topically in patients with facial acne

A Multicenter, Randomized, Investigator-Blind, Parallel Group, Three Arm Pilot Study To Evaluate The Safety And Efficacy of Tazarotene Microsphere Cream 0.09% as compared To Differin (Adapalene) Gel 0.1% And Tazorac (Tazarotene) Cream 0.1% In Once Daily Treatment Of Patients With Moderate Facial Acne Vulgaris For 12 Weeks

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000782

Enrollment

Registered

2009-09-29

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- Moderate Facial Acne Vulgaris

Interventions

Intervention1: Tazarotene Microsphere Cream 0.09%: Once daily topical application over the entire face at bedtime for 12 weeks Control Intervention1: Tazorac (Tazarotene) Cream 0.1%: Once daily topica

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female patients aged 12 to 50 years, with a diagnosis of moderate facial acne vulgaris. 2. Facial inflammatory lesion count >20 and < 50 (both inclusive), non-inflammatory lesions count of atleast 20-100 and IGA score = 3.

Exclusion criteria

Exclusion criteria: Patients with 2 nodulocystic lesions, prior topical acne treatment or systemic anti-inflammatory agents in past 14 days, Systemic corticosteroids, antibacterials, immunosuppressant drugs or abradent facial procedures in the past 30 days, 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.

Design outcomes

Primary

Measure	Time frame
Success rateTimepoint: After 12 weeks of therapy	—

Secondary

Measure	Time frame
Percent reduction in total, inflammatory and non-inflammatory lesion count from baselineTimepoint: Weeks 4, 8 and 12;Reduction in absolute total inflammatory and non-inflammatory lesion count from baselineTimepoint: Weeks 4, 8 and 12	—

Countries

India

Contacts

Public ContactDr Sujala Pathare

Manipal Acunova

shalini.agarwal@ecronacunova.com91-80-66915776

Outcome results

None listed

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