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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02721173
• Other study ID #: T/IM -NF/Derma/15/28
• Status: Completed
• Phase: Phase 4
• First received: March 23, 2016
• Last updated: January 17, 2017
• Start date: April 2016
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: All India Institute of Medical Sciences, Bhubaneswar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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.
• 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.

Locations

Country	Name	City	State
India	AIIMS, Bhubaneswar	Bhubaneswar	Odisha

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, Bhubaneswar

Country where clinical trial is conducted

India, 

References & Publications (10)

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. Review. — View 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. — View 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. — View Citation

Feldman SR, Werner CP, Alió 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. — View 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. — View 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. — View Citation

Millikan LE. The rationale for using a topical retinoid for inflammatory acne. Am J Clin Dermatol. 2003;4(2):75-80. Review. — View 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. — View 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. Review. — View Citation

Thiboutot D, Gollnick H, Bettoli V, Dréno 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 Imp — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Severity of acne	Severity of acne will be assessed by Acne global severity scale	Change from baseline over 4 weeks
Secondary	Severity of acne	Severity of acne will be assessed by Investigator's static global assessment (ISGA) score	Change from baseline over 4 weeks
Secondary	Quality of life	Quality of life will be assessed by Acne-specific quality of life questionnaire (Acne-QoL).	Change from baseline over 4 weeks