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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

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Abstract

Background

Acne vulgaris is a multifactorial disorder which is ideally treated with combination therapy with topical retinoids and antibiotics.

Objectives

The present study was conducted to compare the efficacy and safety of tazarotene plus clindamycin against adapalene plus clindamycin in facial acne vulgaris.

Methods

This study is a randomized, open-label, parallel design clinical trial conducted on 60 patients with facial acne at the outpatient dermatology department in a tertiary healthcare center. The main outcome measures were change in the acne lesion count, Investigator’s Static Global Assessment (ISGA) score, Global Acne Grading System (GAGS) score, and Acne-Specific Quality of Life Questionnaire (Acne-QoL) at the end of 4 weeks of therapy. After randomization one group (n = 30) received tazarotene 0.1% plus clindamycin 1% gel and another group (n = 30) received adapalene 0.1% plus clindamycin 1% gel for 1 month. At follow-up, all the parameter were reassessed.

Result

In both treatment regimens the total number of facial acne lesions decreased significantly. The difference in the change in the total count between the two combination regimens was also significant [6.51, 95% confidence interval (CI) 1.91–11.09, p = 0.007]. A ≥50% reduction in the total lesion count from the baseline levels was achieved by 71% of patients in the tazarotene plus clindamycin group and 22% of patients in the adapalene plus clindamycin group (p = 0.0012). The difference in the change of inflammatory (p = 0.017) and non-inflammatory (p = 0.039) lesion counts in the tazarotene plus clindamycin group were significantly higher than the adapalene plus clindamycin group. The difference in change of the GAGS score was also significantly higher in the tazarotene plus clindamycin group (p = 0.003). The ISGA score improved in 17 patients in the tazarotene plus clindamycin group versusnine patients in the adapalene plus clindamycin group (p = 0.04). The change of total quality-of-life score was found to be significantly (p = 0.027) higher in the tazarotene plus clindamycin group.

Conclusions

Both treatment regimens were efficacious, but tazarotene plus clindamycin was found to be superior to adapalene plus clindamycin. The tolerability profile of both regimens was comparable.

Trial Registration

ClinicalTrials.gov Identifier: NCT02721173

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Acknowledgements

We are thankful to Jay Pearson (Associate Vice President, Acting head, CORE Data Science and Insight), Merck, Sharp & Dohme, Corp., a subsidiary of Merck & Co. Inc., and Tara Robbins (Administrative Assistant, CORE Predictive and Economic Modeling [PEM], UG1C-60) for permitting the use of the Acne-Specific Quality of Life Questionnaire (Acne-QoL) for this study.

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Authors and Affiliations

  1. Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha, India

    Rituparna Maiti, Anand Srinivasan & Debasish Hota

  2. Department of Dermatology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha, India

    Chandra Sekhar Sirka

  3. All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha, India

    M. A. Ashique Rahman

  4. Institute of Medical Sciences and Sum Hospital, Bhubaneswar, Odisha, India

    Sansita Parida

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  1. Rituparna Maiti
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  2. Chandra Sekhar Sirka
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  3. M. A. Ashique Rahman
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  4. Anand Srinivasan
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Corresponding author

Correspondence to Rituparna Maiti.

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Financial disclosure

No source of funding was used to conduct this study

Conflict of interest

Rituparna Maiti, Chandra Sekhar Sirka, MA Ashique Rahman, Anand Srinivasan, Sansita Parida and Debasish Hota have no conflicts of interest to declare.

Ethics approval

The study has been approved by Institutional Ethics Committee (IEC), AIIMS, Bhubaneswar, Odisha, India (Registration no. ECR/534/Inst/OD/2014/RR-17) (vide Ref. no. T/IM-NF/Derma/15/28 Dated 17.03.16). All procedures in this study were in accordance with the 1964 Helsinki Declaration (and its amendments).

Informed consent

Written informed consent was obtained from patients.

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Maiti, R., Sirka, C.S., Ashique Rahman, M.A. et al. 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 37, 1083–1091 (2017). https://doi.org/10.1007/s40261-017-0568-2

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