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

Melasma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00469183
• Other study ID #: US10010
• Status: Completed
• Phase: Phase 4
• Start date: May 2006
• Est. completion date: April 2007

Study information

• Verified date: March 2008
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Same as above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center of Dallas	Dallas	Texas
United States	Vitiligo and Pigmentation Institute of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Skin biopsy evaluation - histological assessment of skin atrophy		Baseline, 12 weeks and 24 weeks
Secondary	Tolerability assessments; Incidence of adverse events; Global Assessment of Lesion Severity; MASI; Physician Global Assessment		Baseline, 12 weeks and 24 weeks