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Evaluation of the safety and efficacy of a triple combination cream (hydroquinone, tretinoin, and fluocinolone) for treatment of melasma in Middle Eastern skin

Authors Ahmad Nasrollahi S, Sabet Nematzadeh M, Samadi A, Ayatollahi A, Yadangi S, Abels C, Firooz A

Received 20 January 2019

Accepted for publication 1 May 2019

Published 10 June 2019 Volume 2019:12 Pages 437—444


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Jeffrey Weinberg

Saman Ahmad Nasrollahi,1,* Maede Sabet Nematzadeh,2,* Aniseh Samadi,1 Azin Ayatollahi,1 Somayeh Yadangi,1 Christoph Abels,3 Alireza Firooz1

1Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences, Tehran, Iran; 2Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Iran; 3Dr. August Wolff GmbH & Co. KG Arzneimittel, Bielefeld, Germany

*These authors contributed equally to this work

Background: Melasma is the most common pigmentary skin disorder, especially in females and those with darker complexion. The current study evaluated the safety and efficacy of a triple combination cream containing hydroquinone 4%+tretinoin 0.05%+fluocinolone acetonide 0.01% (Januluma®, cream produced by Janus Pharmaceutical Co, Tehran, Iran) in the treatment of melasma.
Patients and methods: Twenty-two female volunteers (mean±standard deviation of age: 39.20±4.16 years) who fulfilled the eligibility criteria participated in this study after signing the informed consent. They were requested to apply the Januluma®,cream every night for 8 weeks. Modified melasma area and severity index (mMASI), skin lightness (L value), and severity of pigmentation (E value) by Visio Face, and skin biophysical parameters including pH, melanin index, erythema index, sebum, hydration, trans epidermal water loss, thickness and density of epidermis, and dermis (using 22 MHz ultrasonography) were measured before and 4 and 8 weeks after treatment. Also patients’ satisfaction was assessed 4 and 8 weeks after treatment using visual analog score.
Results: mMASI decreased significantly from 3.37 to 2.60 at week 4, and to 2.40 at week 8 (P-values=0.00 and 0.01, respectively). Also, E and L values improved significantly after 8 weeks of treatment (P=0.01 and 0.00, respectively). Skin melanin index decreased from 237.49 AU to 196.30 AU at week 8 (P=0.01). Also echo density of dermis increased significantly after 8 weeks of treatment (P=0.029). Almost all participants experienced some degrees of pruritus, scaling, and erythema, esspecially during the first month of application, which were generally mild and tolerable. The mean satisfaction of patients with the treatment was 6.77.
Conclusion: The triple combination formula was reasonably safe and effective for treatment of melasma in Middle Eastern patients.

Keywords: melasma, combination therapy, efficacy assessment, Middle Easterners

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