Evidence map›Paper›PMID 39943675›Full record

ArticleJournal of cosmetic dermatology2025

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.

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

Abstract read
In one paragraph

Article in Journal of cosmetic dermatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Mukesh GabhaneEx-Employee, Medical Affairs, Sun Pharma Laboratories Limited, Mumbai, India.
Raji PatilDermatologist, Mascot Spincontrol India Pvt. Ltd., Mumbai, India.
Shruti DharmadhikariMedical Affairs, Sun Pharma Laboratories Limited, Mumbai, India.
Priyank ShahEx-Employee, Medical Affairs, Sun Pharma Laboratories Limited, Mumbai, India.
Chintan KhandhediaMedical Affairs, Sun Pharma Laboratories Limited, Mumbai, India.
Suyog MehtaMedical Affairs, Sun Pharma Laboratories Limited, Mumbai, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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

aimsEfficacy 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).

methodsThis 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.

resultsIn 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.

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

Indexed as

ArbutinFacial DermatosesGlucosidesHydroxybenzoatesMelanosisSunscreening AgentsAdministration, CutaneousAdolescentAdultDrug CombinationsFaceFemaleHumansIndiaMiddle AgedProspective StudiesArbutinDrug CombinationsGlucosidesHydroxybenzoatesSunscreening Agentsdark spotshyperpigmentationmelanin contentmelasmatrihydroxybenzoic acid glucosideα‐arbutin

Identifiers

PMID39943675
PMCPMC11822242

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.