Efficacy and Safety of Therapy With Tri-Luma® Cream in Sequence With Glycolic Acid Peels for Melasma - Tabular View

Tracking Information

First Received Date ^ICMJE

May 10, 2007

Last Updated Date

March 27, 2008

Start Date ^ICMJE

November 2006

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Efficacy - Improvement in Investigator's global assessment of melasma [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Efficacy

Change History

Complete list of historical versions of study NCT00472966 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety - Tolerability assessments and adverse event reporting [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Safety

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of Therapy With Tri-Luma® Cream in Sequence With Glycolic Acid Peels for Melasma

Official Title ^ICMJE

Open Label Study to Evaluate the Efficacy and Safety of Sequential Therapy With Fluocinolone Acetonide 0.01%, Hydroquinone (HQ) 4% and Tretinoin 0.05% (TriLuma® Cream) and a Series of Glycolic Acid Peels for the Treatment of Melasma

Brief Summary

To determine the effectiveness and safety of sequential therapy with of Tri-Luma® Cream and a series of Glycolic Acid peels in treatment of moderate to severe melasma.

Detailed Description

To determine the efficacy and safety of sequential therapy with Fluocinolone acetonide 0.01%, Hydroquinone 4% and Tretinoin 0.05%, and a series of Glycolic Acid peels in the treatment of moderate to severe melasma.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Melasma

Intervention ^ICMJE

Drug: Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels

Study Arms / Comparison Groups

Other: Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels

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 diagnosed with moderate to severe melasma

Exclusion Criteria:

Subjects under treatment for a dermatologic condition, which may interfere with the safe evaluation of the study combination (e.g. eczema, psoriasis, severe sun-damage, dermatitis)
Subjects with a diagnosis of skin cancer (BCE, SCC, Melanoma) in the areas to be treated

Gender

Both

Ages

18 Years and older

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

NCT00472966

Responsible Party

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

Study ID Numbers ^ICMJE

US10031

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