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Trial record 5 of 346 for:    acne AND facial

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02721173
Recruitment Status : Completed
First Posted : March 29, 2016
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Chandra Sekhar Sirka, All India Institute of Medical Sciences, Bhubaneswar

Tracking Information
First Submitted Date  ICMJE March 23, 2016
First Posted Date  ICMJE March 29, 2016
Last Update Posted Date January 18, 2017
Study Start Date  ICMJE April 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02721173 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2016)
  • Severity of acne [ Time Frame: Change from baseline over 4 weeks ]
    Severity of acne will be assessed by Acne global severity scale
  • 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
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tazarotene Plus Clindamycin vs. Adapalene Plus Clindamycin in the Treatment of Facial Acne Vulgaris
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Tazarotene group
    This group will receive tazarotene 0.1% gel plus clindamycin 1% gel for 4 weeks.
    Intervention: Drug: Tazarotene 0.1% gel plus clindamycin 1% gel
  • Active Comparator: Adapalene group
    This group will receive adapalene 0.1% gel plus clindamycin 1% gel for 4 weeks.
    Intervention: Drug: Adapalene 0.1% gel plus clindamycin 1% gel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2017)
60
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2016)
100
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02721173
Other Study ID Numbers  ICMJE T/IM -NF/Derma/15/28
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chandra Sekhar Sirka, All India Institute of Medical Sciences, Bhubaneswar
Study Sponsor  ICMJE All India Institute of Medical Sciences, Bhubaneswar
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: DEBASISH HOTA, DM AIIMS, Bhubaneswar
PRS Account All India Institute of Medical Sciences, Bhubaneswar
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP