Trial Outcomes & Findings for Treatment w/ Tri-Luma® Cream & Intense Pulsed Light (IPL) vs a Mild Inactive Control Cream & Intense Pulsed Light (IPL) in Melasma (NCT NCT00669071)

NCT ID: NCT00669071

Last Updated: 2022-08-23

Results Overview

Number of participants who were a success or failure with regards to melasma severity at Week 10 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

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 56 participants
• Primary outcome timeframe: Baseline to week 10
• Results posted on: 2022-08-23

Participant Flow

Dates of recruitment period: First subject was enrolled on January 8, 2008 and the last subject was enrolled on August 6, 2008.

The specified wash-out period up to baseline was: * 2 weeks since the use of Non-Steroidal Anti- Inflammatory Drugs (NSAIDs) * 14 days for melasma treatments at the time of study entry or under current treatment * at least 6 months since prior facial IPL, resurfacing, deep or chemical peels from the date of study entry

Participant milestones

Measure	IPL / Tri-Luma® Cream and IPL / Inactive Control Cream Intense Pulsed Light (IPL)/fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma® Cream) and Intense Pulsed Light (IPL)/Cetaphil® Moisturizing Cream; 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.
Overall Study STARTED	56
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	IPL / Tri-Luma® Cream and IPL / Inactive Control Cream Intense Pulsed Light (IPL)/fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma® Cream) and Intense Pulsed Light (IPL)/Cetaphil® Moisturizing Cream; 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.
Overall Study Lost to Follow-up	3
Overall Study Final visit 40 days out of window	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	IPL / Tri-Luma® Cream and IPL / Inactive Control Cream n=56 Participants Intense Pulsed Light (IPL)/fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma® Cream) and Intense Pulsed Light (IPL)/Cetaphil® Moisturizing Cream; 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.
Age, Continuous	43.3 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to week 10

Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

Number of participants who were a success or failure with regards to melasma severity at Week 10 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

Outcome measures

Measure	Intense Pulsed Light (IPL) / Tri-Luma® Cream n=56 Participants Intense Pulsed Light (IPL) /fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%	Intense Pulsed Light (IPL) / Inactive Control Cream n=56 Participants Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 10 as Evaluated Using the Investigator's Global Assessment (IGA) of Melasma Success	32 participants	13 participants
Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 10 as Evaluated Using the Investigator's Global Assessment (IGA) of Melasma Failure	24 participants	43 participants
Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 10 as Evaluated Using the Investigator's Global Assessment (IGA) of Melasma Missing	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline to week 6

Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

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

Outcome measures

Measure	Intense Pulsed Light (IPL) / Tri-Luma® Cream n=56 Participants Intense Pulsed Light (IPL) /fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%	Intense Pulsed Light (IPL) / Inactive Control Cream n=56 Participants Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
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 Success	23 participants	8 participants
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 Failure	33 participants	48 participants
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 Missing	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline to Week 6 and Baseline to Week 10

Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

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.

Outcome measures

Measure	Intense Pulsed Light (IPL) / Tri-Luma® Cream n=56 Participants Intense Pulsed Light (IPL) /fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%	Intense Pulsed Light (IPL) / Inactive Control Cream n=56 Participants Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
Degree of Pigmentation (Melanin) Using a Mexameter at Weeks 6 and 10 Week 6	27.5 units on a scale Standard Deviation 52.64	36.7 units on a scale Standard Deviation 49.41
Degree of Pigmentation (Melanin) Using a Mexameter at Weeks 6 and 10 Week 10	15.1 units on a scale Standard Deviation 41.6	26.2 units on a scale Standard Deviation 43.89

SECONDARY outcome

Timeframe: Baseline to week 6

Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

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

Outcome measures

Measure	Intense Pulsed Light (IPL) / Tri-Luma® Cream n=56 Participants Intense Pulsed Light (IPL) /fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%	Intense Pulsed Light (IPL) / Inactive Control Cream n=56 Participants Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Investigator's Evaluation of Improvement Success	46 participants	40 participants
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Investigator's Evaluation of Improvement Failure	7 participants	13 participants
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Investigator's Evaluation of Improvement Missing	3 participants	3 participants

SECONDARY outcome

Timeframe: Baseline to week 10

Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

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

Outcome measures

Measure	Intense Pulsed Light (IPL) / Tri-Luma® Cream n=56 Participants Intense Pulsed Light (IPL) /fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%	Intense Pulsed Light (IPL) / Inactive Control Cream n=56 Participants Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Investigator's Evaluation of Improvement Success	44 participants	37 participants
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Investigator's Evaluation of Improvement Failure	9 participants	16 participants
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Investigator's Evaluation of Improvement Missing	3 participants	3 participants

SECONDARY outcome

Timeframe: Baseline to week 6

Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

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

Outcome measures

Measure	Intense Pulsed Light (IPL) / Tri-Luma® Cream n=56 Participants Intense Pulsed Light (IPL) /fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%	Intense Pulsed Light (IPL) / Inactive Control Cream n=56 Participants Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Subject's Evaluation of Improvement Failure	5 participants	20 participants
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Subject's Evaluation of Improvement Success	48 participants	33 participants
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Subject's Evaluation of Improvement Missing	3 participants	3 participants

SECONDARY outcome

Timeframe: Baseline to week 10

Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

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

Outcome measures

Measure	Intense Pulsed Light (IPL) / Tri-Luma® Cream n=56 Participants Intense Pulsed Light (IPL) /fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%	Intense Pulsed Light (IPL) / Inactive Control Cream n=56 Participants Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Subject's Evaluation of Improvement Success	48 participants	36 participants
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Subject's Evaluation of Improvement Failure	5 participants	17 participants
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Subject's Evaluation of Improvement Missing	3 participants	3 participants

SECONDARY outcome

Timeframe: Baseline to week 10

Population: Safety

Number of participants with Tolerability assessments (erythema, scaling, dryness, stinging/burning, edema, telangiectasis, darkening or melasma spots) resulting in adverse events

Outcome measures

Measure	Intense Pulsed Light (IPL) / Tri-Luma® Cream n=56 Participants Intense Pulsed Light (IPL) /fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%	Intense Pulsed Light (IPL) / Inactive Control Cream n=56 Participants Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
Number of Participants With Tolerability Assessments Resulting in Adverse Events	1 participants	0 participants

Adverse Events

IPL / Tri-Luma® Cream and IPL / Inactive Control Cream

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ronald W. Gottschalk, MD / Medical Director

Galderma Laboratories, L.P.

Phone: 817-961-5358

Email: ron.gottschalk@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee The principal investigator has the right to publish or present the data resulting from this study, with agreed upon reviews by all interested parties, and in accordance with any confidentiality agreements that may exist.
• Publication restrictions are in place

Restriction type: OTHER