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

NCT00469183 | Completed Phase 4

• 1 other identifier: US10010
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

• Safety - Skin biopsy evaluation - histological assessment of skin atrophy

  Baseline, 12 weeks and 24 weeks

Secondary Outcomes (1)

• Tolerability assessments; Incidence of adverse events; Global Assessment of Lesion Severity; MASI; Physician Global Assessment

  Baseline, 12 weeks and 24 weeks

Interventions

Fluocinolone acetonide .1%, hydroquinone 4%, tretinoin .05% DRUG

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

Also known as: TriLuma Cream

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (2)

Vitiligo and Pigmentation Institute of Southern California

Los Angeles, California, 90036, United States

Location

University of Texas Southwestern Medical Center of Dallas

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• Grimes PE, Bhawan J, Guevara IL, Colon LE, Johnson LA, Gottschalk RW, Pandya AG. Continuous therapy followed by a maintenance therapy regimen with a triple combination cream for melasma. J Am Acad Dermatol. 2010 Jun;62(6):962-7. doi: 10.1016/j.jaad.2009.06.067. Epub 2010 Apr 15.

  PMID: 20398959 DERIVED

MeSH Terms

Conditions

Melanosis

Interventions

Fluocinolone Acetonide; hydroquinone

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Ronald W Gottschalk, MD

  Galderma R&D

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 2, 2007
• First Posted: May 4, 2007
• Study Start: May 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: July 29, 2022

Record last verified: 2008-03

Locations

US (2)