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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00472966
Other study ID # US10031
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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