Treatment w/ Tri-Luma® Cream & Intense Pulsed Light (IPL) vs a Mild Inactive Control Cream & Intense Pulsed Light (IPL) in Melasma

Galderma

Status and phase: Terminated; Phase 4

Conditions: Melasma

Treatments: Drug: Cetaphil® Moisturizing Cream as Inactive Control; Drug: Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00669071

US10081

Details and patient eligibility

About

This study is to evaluate the efficacy and safety of Tri-Luma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) when used sequentially with a series of intense pulsed light (IPL) treatments in Subjects diagnosed with moderate to severe melasma during a 10 week treatment period.

Full description

Same as above.

Enrollment: 56 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects diagnosed with moderate to severe melasma on both sides of the face (Investigator's Global Assessment (IGA) at baseline must be 3 or 4.)

Exclusion criteria

• Subjects with a diagnosis of skin cancer (Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC), Melanoma) in the areas to be treated
• Subjects with prior facial Intense Pulsed Light (IPL), resurfacing, deep or chemical peels within 6 months of the date of study entry
• Subject has initiated treatment with hormones including estrogen, progesterone and/or oral contraceptives within 3 months of study entry, or who intend to discontinue hormonal therapy during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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56 participants in 2 patient groups

IPL / Tri-Luma® Cream

Active Comparator group

Treatment:

Drug: Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%

IPL/Cetaphil® Moisturizing Cream as Inactive Control

Active Comparator group

Treatment:

Drug: Cetaphil® Moisturizing Cream as Inactive Control