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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Tazarotene 0.1% gel plus clindamycin 1% gel
Adapalene 0.1% gel plus clindamycin 1% gel
Sponsored by
All India Institute of Medical Sciences, Bhubaneswar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Tazarotene, Adapalene, Clindamycin

Eligibility Criteria

12 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AIIMS, Bhubaneswar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tazarotene group

Adapalene group

Arm Description

This group will receive tazarotene 0.1% gel plus clindamycin 1% gel for 4 weeks.

This group will receive adapalene 0.1% gel plus clindamycin 1% gel for 4 weeks.

Outcomes

Primary Outcome Measures

The number of facial acne lesions
Total number of facial acne lesions (inflammatory and non-inflammatory) will be counted

Secondary Outcome Measures

Severity of acne
Severity of acne will be assessed by Acne global severity scale
Severity of acne
Severity of acne will be assessed by Investigator's static global assessment (ISGA) score
Quality of life
Quality of life will be assessed by Acne-specific quality of life questionnaire (Acne-QoL).

Full Information

First Posted
March 23, 2016
Last Updated
January 17, 2017
Sponsor
All India Institute of Medical Sciences, Bhubaneswar
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1. Study Identification

Unique Protocol Identification Number
NCT02721173
Brief Title
Tazarotene Plus Clindamycin vs. Adapalene Plus Clindamycin in the Treatment of Facial Acne Vulgaris
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, Bhubaneswar

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Tazarotene, Adapalene, Clindamycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tazarotene group
Arm Type
Experimental
Arm Description
This group will receive tazarotene 0.1% gel plus clindamycin 1% gel for 4 weeks.
Arm Title
Adapalene group
Arm Type
Active Comparator
Arm Description
This group will receive adapalene 0.1% gel plus clindamycin 1% gel for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Tazarotene 0.1% gel plus clindamycin 1% gel
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Adapalene 0.1% gel plus clindamycin 1% gel
Intervention Description
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 Outcome Measure Information:
Title
The number of facial acne lesions
Description
Total number of facial acne lesions (inflammatory and non-inflammatory) will be counted
Time Frame
Change from baseline over 4 weeks
Secondary Outcome Measure Information:
Title
Severity of acne
Description
Severity of acne will be assessed by Acne global severity scale
Time Frame
Change from baseline over 4 weeks
Title
Severity of acne
Description
Severity of acne will be assessed by Investigator's static global assessment (ISGA) score
Time Frame
Change from baseline over 4 weeks
Title
Quality of life
Description
Quality of life will be assessed by Acne-specific quality of life questionnaire (Acne-QoL).
Time Frame
Change from baseline over 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DEBASISH HOTA, DM
Organizational Affiliation
AIIMS, Bhubaneswar
Official's Role
Study Director
Facility Information:
Facility Name
AIIMS, Bhubaneswar
City
Bhubaneswar
State/Province
Odisha
ZIP/Postal Code
751019
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12553848
Citation
Millikan LE. The rationale for using a topical retinoid for inflammatory acne. Am J Clin Dermatol. 2003;4(2):75-80. doi: 10.2165/00128071-200304020-00001.
Results Reference
result
PubMed Identifier
12839559
Citation
Jeremy AH, Holland DB, Roberts SG, Thomson KF, Cunliffe WJ. Inflammatory events are involved in acne lesion initiation. J Invest Dermatol. 2003 Jul;121(1):20-7. doi: 10.1046/j.1523-1747.2003.12321.x.
Results Reference
result
PubMed Identifier
18249468
Citation
Do TT, Zarkhin S, Orringer JS, Nemeth S, Hamilton T, Sachs D, Voorhees JJ, Kang S. Computer-assisted alignment and tracking of acne lesions indicate that most inflammatory lesions arise from comedones and de novo. J Am Acad Dermatol. 2008 Apr;58(4):603-8. doi: 10.1016/j.jaad.2007.12.024. Epub 2008 Feb 4.
Results Reference
result
PubMed Identifier
20213916
Citation
Talpur R, Cox K, Duvic M. Efficacy and safety of topical tazarotene: a review. Expert Opin Drug Metab Toxicol. 2009 Feb;5(2):195-210. doi: 10.1517/17425250902721250.
Results Reference
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PubMed Identifier
19376456
Citation
Thiboutot D, Gollnick H, Bettoli V, Dreno B, Kang S, Leyden JJ, Shalita AR, Lozada VT, Berson D, Finlay A, Goh CL, Herane MI, Kaminsky A, Kubba R, Layton A, Miyachi Y, Perez M, Martin JP, Ramos-E-Silva M, See JA, Shear N, Wolf J Jr; Global Alliance to Improve Outcomes in Acne. New insights into the management of acne: an update from the Global Alliance to Improve Outcomes in Acne group. J Am Acad Dermatol. 2009 May;60(5 Suppl):S1-50. doi: 10.1016/j.jaad.2009.01.019.
Results Reference
result
PubMed Identifier
12095065
Citation
Draelos ZD, Tanghetti EA; Tazarotene Combination Leads to Efficacious Acne Results (CLEAR) Trial Study Group. Optimizing the use of tazarotene for the treatment of facial acne vulgaris through combination therapy. Cutis. 2002 Feb;69(2 Suppl):20-9.
Results Reference
result
PubMed Identifier
18472984
Citation
Piskin S, Uzunali E. A review of the use of adapalene for the treatment of acne vulgaris. Ther Clin Risk Manag. 2007 Aug;3(4):621-4.
Results Reference
result
PubMed Identifier
23652892
Citation
Feldman SR, Werner CP, Alio Saenz AB. The efficacy and tolerability of tazarotene foam, 0.1%, in the treatment of acne vulgaris in 2 multicenter, randomized, vehicle-controlled, double-blind studies. J Drugs Dermatol. 2013 Apr;12(4):438-46.
Results Reference
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PubMed Identifier
19439902
Citation
Adityan B, Kumari R, Thappa DM. Scoring systems in acne vulgaris. Indian J Dermatol Venereol Leprol. 2009 May-Jun;75(3):323-6. doi: 10.4103/0378-6323.51258. No abstract available.
Results Reference
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PubMed Identifier
11488820
Citation
Martin AR, Lookingbill DP, Botek A, Light J, Thiboutot D, Girman CJ. Health-related quality of life among patients with facial acne -- assessment of a new acne-specific questionnaire. Clin Exp Dermatol. 2001 Jul;26(5):380-5. doi: 10.1046/j.1365-2230.2001.00839.x.
Results Reference
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PubMed Identifier
28913735
Citation
Maiti R, Sirka CS, Ashique Rahman MA, Srinivasan A, Parida S, Hota D. Efficacy and Safety of Tazarotene 0.1% Plus Clindamycin 1% Gel Versus Adapalene 0.1% Plus Clindamycin 1% Gel in Facial Acne Vulgaris: A Randomized, Controlled Clinical Trial. Clin Drug Investig. 2017 Nov;37(11):1083-1091. doi: 10.1007/s40261-017-0568-2.
Results Reference
derived

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

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