Assessment of Atrophogenic Potential of Triple Combination Cream for Treatment of Melasma - Tabular View

Tracking Information

First Received Date ^ICMJE

May 2, 2007

Last Updated Date

March 28, 2008

Start Date ^ICMJE

May 2006

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety - Skin biopsy evaluation - histological assessment of skin atrophy [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Safety

Change History

Complete list of historical versions of study NCT00469183 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Tolerability assessments; Incidence of adverse events; Global Assessment of Lesion Severity; MASI; Physician Global Assessment [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Efficacy

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Same as above.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^ICMJE

Melasma

Intervention ^ICMJE

Drug: Fluocinolone acetonide .1%, hydroquinone 4%, tretinoin .05%

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2007

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00469183

Responsible Party

Ronald W. Gottschalk, MD / Medical Director, Galderma laboratories, L.P.

Study ID Numbers ^ICMJE

US10010

Study Sponsor ^ICMJE

Galderma Laboratories, L.P.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Ronald W Gottschalk, MD

Galderma Laboratories, L.P.

Information Provided By

Galderma Laboratories, L.P.

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP