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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-04-30

Brief Summary

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

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Detailed Description

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Same as above.

Conditions

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Melasma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Fluocinolone 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

Intervention Type DRUG

Other Intervention Names

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TriLuma Cream

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No