Tazarotene Plus Clindamycin vs. Adapalene Plus Clindamycin in the Treatment of Facial Acne Vulgaris

January 17, 2017 updated by: Chandra Sekhar Sirka, All India Institute of Medical Sciences, Bhubaneswar

Comparison of Safety and Efficacy of Tazarotene 0.1% Plus Clindamycin 1% Gel vs. Adapalene 0.1% Plus Clindamycin 1% Gel in the Treatment of Facial Acne Vulgaris: A Randomized Controlled Trial

The combination therapy of retinoid and clindamycin for acne is preferred because it targets multiple areas of acne pathogenesis that could not be accomplished with monotherapy, thereby improving outcome. Literature review reveals that till date there is no published comparative study assessing safety and efficacy of tazarotene plus clindamycin and adapalene plus clindamycin. So the present study has been designed to compare these two combination therapy in acne vulgaris.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acne vulgaris is one of the most common disorders treated by dermatologists. The pathogenesis of acne is multifactorial. Critical components include abnormal follicular keratinocyte desquamation leading to the formation of a follicular plug (microcomedo), increase of sebum production in pilosebaceous unit, colonization by Propionibacterium acnes, and inflammation. Topical retinoids, which target comedogenesis and have anti-inflammatory activity, are recommended as first-line therapy for both inflammatory and non-inflammatory acne. The adjunctive use of anti-acne agents like clindamycin by its complementary mechanism of action can help to enhance the efficacy of topical retinoid therapy still further.

Tazarotene is a synthetic retinoid and a prodrug that is converted by the skin to its active form, tazarotenic acid. The active form binds to retinoic acid receptors (RARs) and regulates gene transcription and helps to normalize the abnormal keratinization in the follicular infundibulum, this in turn changes the microenvironment of the follicle and thereby reduce the proliferation of Propionibacterium acnes. Adapalene is a synthetic naphthoic acid derivative with retinoid activity. Adapalene also acts through RARs and modulates cellular keratinization and inflammatory process. Clindamycin is bactericidal to Propionibacterium acnes. Due to the inhibition of P. acnes the free fatty acid levels in the pilosebaceous unit of skin is also reduced. Clindamycin phosphate applied topically penetrates to a very great extent to open comedones and thus produces a high percentage of sterile comedones.

The combination therapy of retinoid and clindamycin for acne is preferred because it targets multiple areas of acne pathogenesis that could not be accomplished with monotherapy, thereby improving outcome. Literature review reveals that till date there is no published comparative study assessing safety and efficacy of tazarotene plus clindamycin and adapalene plus clindamycin. So the present study has been designed to compare these two combination therapy in acne vulgaris.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Odisha
      • Bhubaneswar, Odisha, India, 751019
        • AIIMS, Bhubaneswar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients with the diagnosis of facial acne vulgaris having comedones, papules, pustules (≤5), or nodules (≤2) or Investigator's static global assessment score ≤4
  • Treatment naïve patients or patients who had not taken topical anti-acne medications in last 14 days, systemic antibiotics in last 30 days, oral retinoids in last 12 months

Exclusion Criteria:

  • Very severe acne vulgaris (Investigator's static global assessment score >4)
  • Any skin disorder that might interfere with the diagnosis or evaluation of acne vulgaris
  • Known hypersensitivity to retinoids and clindamycin
  • Any uncontrolled systemic disease or any cosmetic or surgical procedures complementary to the treatment of acne in the preceding 15 days
  • Patients who were on oral contraceptive pills in last 12 weeks
  • Pregnant and nursing women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tazarotene group
This group will receive tazarotene 0.1% gel plus clindamycin 1% gel for 4 weeks.
Drug: Tazarotene 0.1% gel plus clindamycin 1% gel
Medications will be advised to apply once daily in the evening after facial cleansing. Clindamycin will be applied first and tazarotene will be applied 5-10 minutes later.
Active Comparator: Adapalene group
This group will receive adapalene 0.1% gel plus clindamycin 1% gel for 4 weeks.
Drug: Adapalene 0.1% gel plus clindamycin 1% gel
Medications will be advised to apply once daily in the evening after facial cleansing. Clindamycin will be applied first and adapalene will be applied 5-10 minutes later.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of facial acne lesions
Time Frame: Change from baseline over 4 weeks
Total number of facial acne lesions (inflammatory and non-inflammatory) will be counted
Change from baseline over 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of acne
Time Frame: Change from baseline over 4 weeks
Severity of acne will be assessed by Acne global severity scale
Change from baseline over 4 weeks
Severity of acne
Time Frame: Change from baseline over 4 weeks
Severity of acne will be assessed by Investigator's static global assessment (ISGA) score
Change from baseline over 4 weeks
Quality of life
Time Frame: Change from baseline over 4 weeks
Quality of life will be assessed by Acne-specific quality of life questionnaire (Acne-QoL).
Change from baseline over 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, Bhubaneswar

Investigators

  • Study Director: DEBASISH HOTA, DM, AIIMS, Bhubaneswar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

March 23, 2016

First Submitted That Met QC Criteria

March 25, 2016

First Posted (Estimate)

March 29, 2016

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T/IM -NF/Derma/15/28

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acne Vulgaris

Clinical Trials on Tazarotene 0.1% gel plus clindamycin 1% gel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe