A clinical trial to study the effect of Fixed Dose Combination of Microsphere Tretinoin and Clindamycin gel in the treatment of patients with acne vulgaris.

Phase 3

Completed

• Conditions: Acne Vulgaris

• Registration Number: CTRI/2012/03/002472
• Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary

This is double-blind, randomized, active controlled, three arm, parallel-group, comparative study. Study will enroll 438 patients with acne vulgaris across the different centers from India.    xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Patients will be recruited after providing written informed consent. After screening, patients will be randomized (meeting randomization criteria) in 1:1:1 ratios to receive either Fixed Dose Combination of Microsphere Tretinoin and Clindamycin gel or Clindamycin gel or Microsphere Tretinoin gel for twelve weeks. The primary objective of the study is to see the absolute change in lesion counts and Investigator’s Static Global Assessment success. Secondary objective includes; percentage change in lesion counts, proportion of patients who had a Subject Global Assessment Score of 0 or 1 at Week 12, proportion of patients who had an ISGA score of 0 or 1 at Week 12 and safety evaluation.

During the study, there will be 5 study visits at day 1, week 2, 4, 8 and 12 for efficacy, safety and tolerability assessment.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-03
• Last Update Posted: 2012-12-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 438

Inclusion Criteria

• 1.Male or female ≥12 to <65 years and willing to give their written informed consent.
• 2.An Investigator’s Static Global Assessment (ISGA) Score of 2 or greater at baseline 3.Subjects must have both: a)A minimum of 17 but no more than 40 facial inflammatory lesions; b)A minimum of 20 but not more than 150 facial non-inflammatory lesions 4.The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
• 5.Female participants must have a negative pregnancy test at screening visit and willing to use acceptable contraceptive measures during the study.
• 6.The ability to understand and sign written informed consent form, which must have been obtained prior to applying the study product.
• Subjects under the legal age of consent must provide assent and have the written informed consent of the parent or guardian.

Exclusion Criteria

• 1.Pregnant or lactating women.
• 2.Patient with known hypersensitivity to any of the components of the formulation.
• 5.History or presence at entry of regional enteritis or inflammatory bowel disease or similar symptoms.
• 6.A significant medical history of or are currently immunocompromised.
• 8.Current drug or alcohol abuse at the time of entry 9.Any other condition which, in the judgment of the investigator, would put the Patient at unacceptable risk for participation in the study.
• 10.Patient who has clinical laboratory evaluations (including biochemistry, hematology, and complete urinalysis) that are not within the reference range for the testing laboratory at Screening and the results are deemed clinically significant by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.Investigator’s Static Global Assessment Success	12 weeks
1.Absolute Change in Lesion counts	12 weeks

Secondary Outcome Measures

Name	Time	Method
1.Percentage change in lesion counts
2.Proportion of patients who had a Subject Global Assessment Score of 0 or 1	12 weeks
3.Proportion of Patients who had an ISGA Score of 0 or 1	12 weeks
4.Change in Vital signs, Physical Exam. & Lab Parameters	12 weeks

Trial Locations

Locations (21)

Agarwal Skin & Laser Centre; 🇮🇳 Indore, MADHYA PRADESH, India

Bhatia Skin Laser & Cosmetic Centre; 🇮🇳 Indore, MADHYA PRADESH, India

Calcutta National Medical College & Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Dayal Clinic; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Dermo Care; 🇮🇳 Krishna, ANDHRA PRADESH, India

Doctors & Doctors; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Dr. Sailaja Kaza Institute & Dr. Surapaneni’s Asthetic Surgery Institute; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Mahatma Gandhi Medical College & Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Medical College, Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

Pace Clinical Research; 🇮🇳 Bangalore, KARNATAKA, India

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Agarwal Skin & Laser Centre

🇮🇳Indore, MADHYA PRADESH, India

Dr Meetesh Agarwal

Principal investigator

919827317412

drmeetesh@yahoo.co.in