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Trial record 12 of 232 for:    clindamycin

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

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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

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Tazarotene 0.1% gel plus clindamycin 1% gel Drug: Adapalene 0.1% gel plus clindamycin 1% gel Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   12 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721173


Locations
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India
AIIMS, Bhubaneswar
Bhubaneswar, Odisha, India, 751019
Sponsors and Collaborators
All India Institute of Medical Sciences, Bhubaneswar
Investigators
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Study Director: DEBASISH HOTA, DM AIIMS, Bhubaneswar

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chandra Sekhar Sirka, Associate Professor, All India Institute of Medical Sciences, Bhubaneswar
ClinicalTrials.gov Identifier: NCT02721173     History of Changes
Other Study ID Numbers: T/IM -NF/Derma/15/28
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chandra Sekhar Sirka, All India Institute of Medical Sciences, Bhubaneswar:
Tazarotene
Adapalene
Clindamycin
Additional relevant MeSH terms:
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Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Nicotinic Acids
Adapalene
Tazarotene
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Keratolytic Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances