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

Melasma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00472966
• Other study ID #: US10031
• Status: Completed
• Phase: Phase 4
• Start date: November 2006
• Est. completion date: April 2007

Study information

• Verified date: March 2008
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

Drug:
• Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels
Apply cream once daily at night. Subjects will be asked to discontinue use of Fluocinolone acetonide/hydroquinone/tretinoin Cream 2 days prior to the peel and restart 2 days after the peel; Glycolic Acid Peels - In office treatment at weeks 2, 4, 6, 8 and 10

Locations

Country	Name	City	State
United States	Skin Care Research, Inc.	Boca Raton	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy - Improvement in Investigator's global assessment of melasma		12 weeks
Secondary	Safety - Tolerability assessments and adverse event reporting		12 weeks