Efficacy and Safety of a Topical Formulation Containing Trihydroxybenzoic Acid Glucoside and α-Arbutin, Applied Along With a Sunscreen: A Noncomparative, Prospective, Interventional Study in Indian Females With Facial Melasma or Dark Spots

IF 2.3 4区医学 Q2 DERMATOLOGY

Journal of Cosmetic Dermatology Pub Date : 2025-02-12 DOI:10.1111/jocd.70017

Mukesh Gabhane, Raji Patil, Shruti Dharmadhikari, Priyank Shah, Chintan Khandhedia, Suyog Mehta

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Abstract

Background

Skin hyperpigmentation is a dermatological concern for pigmented skin phototypes. Despite availability of multiple treatment options, hyperpigmentation management continues to be a challenge.

Aims

Efficacy and safety assessment of the skincare regimen [topical formulation of trihydroxybenzoic acid glucoside 10% (THBG) and α-arbutin 2% (twice-daily) + sunscreen (once daily)] in Indian females with pigmentary spots (facial dark spots or melasma).

Methods

This prospective, open-label, single-arm, interventional study was conducted in Indian females (n = 124), aged 18–45 years, having FitzPatrick skin type III–IV, dull skin, and facial dark spots or melasma. Efficacy of 90-day skincare regimen was evaluated using mexameter, modified melasma area and severity index (mMASI) score, cross-polarized light photography, chromameter, and color–luminosity–brightness–transparency (CLBT) technique. Student's t-test (paired data) was used for statistical analysis.

Results

In efficacy analysis [modified intention-to-treat (mITT) population], 120 subjects were included. Melanin content of pigmentary spots (on mexametry) significantly reduced (−16.3%, p < 0.001) at Day 90 versus baseline. Significant reduction in severity of melasma was observed (−18.4% in mMASI score) at Day 90. Significant improvement in ΔEab (−8.7%) (change in color difference between pigmentary spot and normal skin) on cross-polarized photographs, in skin-brightening parameters L* (relative brightness/lightness) (−2.7%), ITA° (individual typology angle) (−37.7%), and ΔE* (skin-tone evenness) (−19.0%) using chromameter. Significant improvement in skin radiance was observed in CLBT parameters, color (pink: 32.8%, yellow: –5.5%, and olive: −7.8%), luminosity (6.0%), brightness (4.6%), and transparency (0.2%). Regimen did not cause itching, burning, or irritation.

Conclusions

Skincare regime of 10% THBG and 2% α-arbutin along with sunscreen was effective in reducing pigmentary spots (dark spots and melasma) and was well tolerated in Indian women.

Trial Registration: Clinical Trial Registry of India (CTRI Reg. No. CTRI/2021/11/038345; date: 30/11/2021)

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来源期刊

Journal of Cosmetic Dermatology DERMATOLOGY-

CiteScore

4.30

自引率

13.00%

发文量

818

审稿时长

>12 weeks

期刊介绍： The Journal of Cosmetic Dermatology publishes high quality, peer-reviewed articles on all aspects of cosmetic dermatology with the aim to foster the highest standards of patient care in cosmetic dermatology. Published quarterly, the Journal of Cosmetic Dermatology facilitates continuing professional development and provides a forum for the exchange of scientific research and innovative techniques. The scope of coverage includes, but will not be limited to: healthy skin; skin maintenance; ageing skin; photodamage and photoprotection; rejuvenation; biochemistry, endocrinology and neuroimmunology of healthy skin; imaging; skin measurement; quality of life; skin types; sensitive skin; rosacea and acne; sebum; sweat; fat; phlebology; hair conservation, restoration and removal; nails and nail surgery; pigment; psychological and medicolegal issues; retinoids; cosmetic chemistry; dermopharmacy; cosmeceuticals; toiletries; striae; cellulite; cosmetic dermatological surgery; blepharoplasty; liposuction; surgical complications; botulinum; fillers, peels and dermabrasion; local and tumescent anaesthesia; electrosurgery; lasers, including laser physics, laser research and safety, vascular lasers, pigment lasers, hair removal lasers, tattoo removal lasers, resurfacing lasers, dermal remodelling lasers and laser complications.