Skip to main content
OpenTrials
Completed

NCT Number: NCT02721173

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

12 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AIIMS, Bhubaneswar

Bhubaneswar, Odisha, 751019, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tazarotene 0.1% gel plus clindamycin 1% gel

Drug

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.

Adapalene 0.1% gel plus clindamycin 1% gel

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Severity of acne

    Time frame: Change from baseline over 4 weeks

    Severity of acne will be assessed by Acne global severity scale

  2. 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

  3. 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).

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences, Bhubaneswar

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Mar 29, 2016
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.