Efficacy and Safety of Therapy With Tri-Luma® Cream in Sequence With Glycolic Acid Peels for Melasma

Open Label Study to Evaluate the Efficacy and Safety of Sequential Therapy With Fluocinolone Acetonide 0.01%, Hydroquinone (HQ) 4% and Tretinoin 0.05% (TriLuma® Cream) and a Series of Glycolic Acid Peels for the Treatment of Melasma

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00472966

Enrollment

Registered

2007-05-14

Start date

2006-11-30

Completion date

2007-04-30

Last updated

2022-07-29

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

Conditions

Melasma

Brief summary

To determine the effectiveness and safety of sequential therapy with of Tri-Luma® Cream and a series of Glycolic Acid peels in treatment of moderate to severe melasma.

Detailed description

To determine the efficacy and safety of sequential therapy with Fluocinolone acetonide 0.01%, Hydroquinone 4% and Tretinoin 0.05%, and a series of Glycolic Acid peels in the treatment of moderate to severe melasma.

Interventions

DRUGFluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels

Apply cream once daily at night. Subjects will be asked to discontinue use of Fluocinolone acetonide/hydroquinone/tretinoin Cream 2 days prior to the peel and restart 2 days after the peel; Glycolic Acid Peels - In office treatment at weeks 2, 4, 6, 8 and 10

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects diagnosed with moderate to severe melasma

Exclusion criteria

* Subjects under treatment for a dermatologic condition, which may interfere with the safe evaluation of the study combination (e.g. eczema, psoriasis, severe sun-damage, dermatitis) * Subjects with a diagnosis of skin cancer (BCE, SCC, Melanoma) in the areas to be treated

Design outcomes

Primary

Measure	Time frame
Efficacy - Improvement in Investigator's global assessment of melasma	12 weeks

Secondary

Measure	Time frame
Safety - Tolerability assessments and adverse event reporting	12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026