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Completed

NCT Number: NCT00469183

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

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

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Key information

Conditions

Melasma Hyperpigmentation Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vitiligo and Pigmentation Institute of Southern California, Los Angeles, California, United States

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About this study

Same as above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: TriLuma Cream

Primary outcomes

  1. Safety - Skin biopsy evaluation - histological assessment of skin atrophy

    Time frame: Baseline, 12 weeks and 24 weeks

Secondary outcomes

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

    Time frame: Baseline, 12 weeks and 24 weeks

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 4, 2007
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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