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

NCT02721173 | Completed Phase 4

• 1 other identifier: T/IM -NF/Derma/15/28
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Keywords

Tazarotene; Adapalene; Clindamycin

Outcome Measures

Primary Outcomes (1)

• The number of facial acne lesions

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

  Change from baseline over 4 weeks

Secondary Outcomes (3)

• Severity of acne

  Change from baseline over 4 weeks

• Severity of acne

  Change from baseline over 4 weeks

• Quality of life

  Change from baseline over 4 weeks

Study Arms (2)

Tazarotene group

EXPERIMENTAL

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

Drug: Tazarotene 0.1% gel plus clindamycin 1% gel

Adapalene group

ACTIVE COMPARATOR

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

Drug: Adapalene 0.1% gel plus clindamycin 1% gel

Interventions

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.

Tazarotene group

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.

Adapalene group

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

AIIMS, Bhubaneswar

Bhubaneswar, Odisha, 751019, India

Location

Related Publications (11)

• 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.

  PMID: 12553848 RESULT

• 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.

  PMID: 12839559 RESULT

• 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.

  PMID: 18249468 RESULT

• 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.

  PMID: 20213916 RESULT

• 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.

  PMID: 19376456 RESULT

• 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.

  PMID: 12095065 RESULT

• 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.

  PMID: 18472984 RESULT

• 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.

  PMID: 23652892 RESULT

• 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.

  PMID: 19439902 RESULT

• 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.

  PMID: 11488820 RESULT

• 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.

  PMID: 28913735 DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Interventions

tazarotene; Gels; Clindamycin; Adapalene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• DEBASISH HOTA, DM

  AIIMS, Bhubaneswar

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: March 29, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: January 18, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)