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

• Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 6 Using the Investigator's Global Assessment (IGA) of Melasma With Clear/Almost Clear Being Success and All Others Being Failure [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  Number of participants who were a success or failure with regards to melasma severity at Week 6 as evaluated using the Investigator's Global Assessment (IGA) of melasma (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe) with Clear / Almost Clear being success and all others being failure
• Degree of Pigmentation (Melanin) Using a Mexameter at Weeks 6 and 10 [ Time Frame: Baseline to Week 6 and Baseline to Week 10 ] [ Designated as safety issue: No ]
  Degree of pigmentation (melanin) using a Mexameter to record units on a scale at Weeks 6 and 10; units on a scale is a number that represents the presence or absence of melanin in the skin on a scale from 0 - 999 units with 0 units representing no melanin and 999 units representing the maximum amount of melanin.
• Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Investigator's Evaluation of Improvement [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  Number of participants showing success or failure in improvement of melasma at Week 6 using the Investigator's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure
• Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Investigator's Evaluation of Improvement [ Time Frame: Baseline to week 10 ] [ Designated as safety issue: No ]
  Number of participants showing success or failure in improvement of melasma at Week 10 using the Investigator's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure
• Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Subject's Evaluation of Improvement [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  Number of participants showing success or failure in improvement of melasma at Week 6 using the Subject's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure
• Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Subject's Evaluation of Improvement [ Time Frame: Baseline to week 10 ] [ Designated as safety issue: No ]
  Number of participants showing success or failure in improvement of melasma at Week 10 using the Subject's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure
• Number of Participants With Tolerability Assessments Resulting in Adverse Events [ Time Frame: Baseline to week 10 ] [ Designated as safety issue: Yes ]
  Number of participants with Tolerability assessments (erythema, scaling, dryness, stinging/burning, edema, telangiectasis, darkening or melasma spots) resulting in adverse events

• Melasma severity at Week 6 as evaluated using the Investigator's Global Assessment of melasma (IPL/Tri-Luma® Cream side vs. IPL/Inactive Control Cream side) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Degree of pigmentation using a Mexameter at Weeks 6 and 10 (IPL/Tri-Luma® Cream side vs. IPL/Inactive Control Cream side) [ Time Frame: 6 and 10 weeks ] [ Designated as safety issue: No ]
• Improvement in melasma at Weeks 6 and 10 as evaluated using the Investigator's and Subject's evaluation of improvement (IPL/Tri-Luma® Cream side vs. IPL/Inactive Control Cream side) [ Time Frame: 6 and 10 weeks ] [ Designated as safety issue: No ]
• Tolerability assessments and incidence of adverse events [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

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.

Same as above.

• Drug: Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
  Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
  Other Name: Tri-Luma® Cream
• Drug: Cetaphil® Moisturizing Cream as Inactive Control
  Applied once daily at bedtime on the opposite side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
  Other Name: Cetaphil® Moisturizing Cream

• Active Comparator: IPL / Tri-Luma® Cream
  Intervention: Drug: Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
• Active Comparator: IPL/Cetaphil® Moisturizing Cream as Inactive Control
  Intervention: Drug: Cetaphil® Moisturizing Cream as Inactive Control

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