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

Galderma

Status and phase

Completed

Phase 4

Conditions

Melasma

Treatments

Drug: Fluocinolone acetonide .1%, hydroquinone 4%, tretinoin .05%

Study type

Interventional

Funder types

Industry

Identifiers

US10010

Details and patient eligibility

About

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

Full description

Same as above.

Enrollment

70 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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