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

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00469183
• Collaborator: (none)
• Enrollment: 70
• Locations: 2
• Duration (Months): 11
• Patients Per Site: 35
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Melasma	Drug: Fluocinolone acetonide .1%, hydroquinone 4%, tretinoin .05%	Phase 4

Detailed Description

Same as above.

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Assessment of the Atrophogenic Potential of Triple Combination Cream Using Histology Measures in the Treatment of Moderate to Severe Melasma
• Study Start Date: May 1, 2006
• Actual Primary Completion Date: Apr 1, 2007
• Actual Study Completion Date: Apr 1, 2007

Outcome Measures

Primary Outcome Measures

1. Safety - Skin biopsy evaluation - histological assessment of skin atrophy [Baseline, 12 weeks and 24 weeks]

Secondary Outcome Measures

1. Tolerability assessments; Incidence of adverse events; Global Assessment of Lesion Severity; MASI; Physician Global Assessment [Baseline, 12 weeks and 24 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vitiligo and Pigmentation Institute of Southern California	Los Angeles	California	United States	90036
2	University of Texas Southwestern Medical Center of Dallas	Dallas	Texas	United States	75390

Sponsors and Collaborators

• Galderma R&D

Investigators

• Study Director: Ronald W Gottschalk, MD, Galderma R&D

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00469183
• Other Study ID Numbers: US10010
• First Posted: May 4, 2007
• Last Update Posted: Jul 29, 2022
• Last Verified: Mar 1, 2008

• Additional relevant MeSH terms: Melanosis; Fluocinolone Acetonide; Tretinoin; Hydroquinone

Study Results

No Results Posted as of Jul 29, 2022