To study the efficacy of using a combination of a topical Triple combination cream with Fractional CO2 laser in the treatment of facial melasma compared to Triple combination cream alone

To evaluate the effectiveness and safety of topical triple therapy formulation with fractional CO2 laser and triple therapy alone in the treatment of melasma in a split face randomized control study.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/04/018702

Enrollment

Registered

2019-04-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: L811- Chloasma

Interventions

Intervention1: topical triple therapy (Hydroquinone 4%, Tretinoin 0.05%, Fluocinolone acetonide 0.01%) Fractional CO2 laser: A combination of topical triple therapy (Hydroquinone 4%, Tretinoin 0

Eligibility

Inclusion criteria

Inclusion criteria: a. Patients with clinical diagnosis ofbilateral melasma b. More than 18 years of age of either sex c. Patients not on any topical or systemic treatment for melasma in the last 4 weeks.

Exclusion criteria

Exclusion criteria: a. Pregnant or lactating females b. Patients on oral contraceptives, hormone replacement therapy in the last three months c. Patients with any significant disease of gastrointestinal, hepatic, renal, pulmonary, hematological or endocrine system. d. Patients with photosensitive disorders like lupus erythematosus, porphyria, etc. e. History of known hypersensitivity to the interventional agents used in the study like fractional lasers, topical hydroquinone, retinoic acid and corticosteroids.

Design outcomes

Primary

Measure	Time frame
ASSESSMENT PARAMETERS Physicians global assessment scale Patients global assessment scale Photographic assessment by physician Change in modified MASI score from baseline Change in melanin index from baselineTimepoint: ASSESSMENT PARAMETERS Parameters will be assessed every monthly for a total duration of 6 months	—

Secondary

Measure	Time frame
NATimepoint: NA	—

Countries

India

Contacts

Public ContactUtpal Patel

All India Institue of Medical Science

prokverma@hotmail.com01126593454

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026