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

NCT00469183 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-07-29

No results posted yet for this study

Summary

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

Conditions

  • Melasma

Interventions

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

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Principal Investigators

  • Ronald W Gottschalk, MD · Galderma R&D

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-04-30
Completion
2007-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00469183 on ClinicalTrials.gov