Assessment of Atrophogenic Potential of Triple Combination Cream for Treatment of Melasma

An Assessment of the Atrophogenic Potential of Triple Combination Cream Using Histology Measures in the Treatment of Moderate to Severe Melasma

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00469183

Enrollment

Registered

2007-05-04

Start date

2006-05-31

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

Evaluate atrophogenic potential of long-term use of Tri-Luma Cream on facial Melasma through biopsy examination.

Detailed description

Same as above.

Interventions

DRUGFluocinolone acetonide .1%, hydroquinone 4%, tretinoin .05%

Apply topically daily for 12 weeks and continue until condition is clear or almost clear for up to 24 weeks; Maintenance phase: Apply topically twice weekly until the end of study (24 weeks) or condition relapses

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Subjects must have a clinical diagnosis of moderate to severe melasma * Subjects willing to undergo biopsy four times throughout the study, two biopsies at baseline (one in a melasma involved area and one in a non-involved area). The third and fourth biopsies will be performed at 3 months and 6 months, respectively; in order to avoid variability in histopathological findings, * Subjects must have substantial melasma involvement of the cheeks and be willing to have the same general site biopsied at the baseline, month 3 and month 6 visits.

Exclusion criteria

* Subjects with diagnosis of dermal melasma * Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.) * Subjects who have used retinoids, steroids, and/or skin lightening products 4 weeks prior to study entry * Subjects who show signs of Poikiloderma of Civatte (mandibular hyperpigmentation) * Subjects with a history of hypertrophic scarring or a history of keloids * Subjects who are unable to avoid the use of a class 1 steroid during their participation in the study

Design outcomes

Primary

Measure	Time frame
Safety - Skin biopsy evaluation - histological assessment of skin atrophy	Baseline, 12 weeks and 24 weeks

Secondary

Measure	Time frame
Tolerability assessments; Incidence of adverse events; Global Assessment of Lesion Severity; MASI; Physician Global Assessment	Baseline, 12 weeks and 24 weeks

Countries

United States

Outcome results

None listed

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