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A pilot study of effectiveness of a topical cosmetic containing 5% alpha-arbutin combination with 2% kojic acid comparing with triple combination cream in treatment of melasma : A split-face, evaluator blinded randomized trial

A pilot study of effectiveness of a topical cosmetic containing 5% alpha-arbutin combination with 2% kojic acid comparing with triple combination cream in treatment of melasma : A split-face, evaluator blinded randomized trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230124004
Enrollment
30
Registered
2023-01-24
Start date
2022-04-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melasma Melasma, Melasma treatment, Triple combination cream, 5% Alpha-Arbutin, 2% Kojic acid

Interventions

The patients were enrolled and randomized to triple combination cream on the other sided of face. The duration of treatment is twelve weeks, with four-weekly follow-ups throughout and after end of t
Experimental Drug,Experimental Drug
a topical containing 5% alpha-arbutin and 2% kojic acid ,triple combination cream

Sponsors

Institute of dermatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 60 Years

Inclusion criteria

Inclusion criteria: adult between 25- 60 years having a clinical diagnosis of bilateral melasma.

Exclusion criteria

Exclusion criteria: allergic to alpha-arbutin, kojic acid, hydroquinone, tretinoin and fluocinolone acetonide, using medication including hydroquinone, azelaic acid, retinoid, tranexamic acid, skin care products containing AHA, Niacinamide, ascorbic acid, history of chemical peeling and LASER within three months prior to enrolling in the study, pregnancy and lactation.

Design outcomes

Primary

MeasureTime frame
Melasma 4th wk, 8th wk, 12th wk and after discontinuing treatment 4 wks Hemi-mMASI score,Melasma 4th wk, 8th wk, 12th wk and after discontinuing treatment 4 wks Melanin index,Melasma 4th wk, 8th wk, 12th wk Physician global assessment score

Secondary

MeasureTime frame
Side effect 4th wk, 8th wk, 12th wk and after discontinuing treatment 4 wks Investigator assesment,Patient satisfaction after completing of treatment (12 weeks) Patient assessment

Countries

Thailand

Contacts

Public ContactApinya Sripha

Institute of dermatology

a.sripha@gmail.com0922601962

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026