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

This study has been terminated.

(Enrollment closed)

Sponsor:

Information provided by (Responsible Party):

Galderma Laboratories, L.P.

ClinicalTrials.gov Identifier:

NCT00669071

First received: April 24, 2008

Last updated: September 21, 2012

Last verified: September 2012

History of Changes

Results First Received: September 25, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Single Blind (Outcomes Assessor); Primary Purpose: Treatment
Condition:	Melasma
Interventions:	Drug: Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% Drug: Cetaphil® Moisturizing Cream as Inactive Control

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Dates of recruitment period: First subject was enrolled on January 8, 2008 and the last subject was enrolled on August 6, 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

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

Reporting Groups

	Description
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.

Description

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.

Participant Flow: Overall Study

	IPL / Tri-Luma® Cream and IPL / Inactive Control Cream
STARTED	56
COMPLETED	52
NOT COMPLETED	4
Lost to Follow-up	3
Final visit 40 days out of window	1

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
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.

Description

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

Baseline Measures

	IPL / Tri-Luma® Cream and IPL / Inactive Control Cream
Number of Participants [units: participants]	56
Age [units: years] Mean ± Standard Deviation	43.3 ± 9.0
Gender [units: participants]
Female	56
Male	0

Outcome Measures

Show All Outcome Measures

1. Primary:

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 [ Time Frame: Baseline to week 10 ]

Show Outcome Measure 1

2. Secondary:

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 ]

Show Outcome Measure 2

3. Secondary:

Degree of Pigmentation (Melanin) Using a Mexameter at Weeks 6 and 10 [ Time Frame: Baseline to Week 6 and Baseline to Week 10 ]

Show Outcome Measure 3

4. Secondary:

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 ]

Show Outcome Measure 4

5. Secondary:

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 ]

Show Outcome Measure 5

6. Secondary:

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 ]

Hide Outcome Measure 6

Measure Type	Secondary
Measure Title	Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Subject's Evaluation of Improvement
Measure Description	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
Time Frame	Baseline to week 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

Reporting Groups

	Description
Intense Pulsed Light (IPL) / Tri-Luma® Cream	Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
Intense Pulsed Light (IPL) / Inactive Control Cream	Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream

Measured Values

	Intense Pulsed Light (IPL) / Tri-Luma® Cream	Intense Pulsed Light (IPL) / Inactive Control Cream
Number of Participants Analyzed [units: participants]	56	56
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Subject's Evaluation of Improvement [units: participants]
Success	48	33
Failure	5	20
Missing	3	3

No statistical analysis provided for Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Subject's Evaluation of Improvement

7. Secondary:

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 ]

Show Outcome Measure 7

8. Secondary:

Number of Participants With Tolerability Assessments Resulting in Adverse Events [ Time Frame: Baseline to week 10 ]

Show Outcome Measure 8

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Ronald W. Gottschalk, MD / Medical Director
Organization: Galderma Laboratories, L.P.
phone: 817-961-5358
e-mail: ron.gottschalk@galderma.com

No publications provided

Responsible Party:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00669071 History of Changes
Other Study ID Numbers:	US10081
Study First Received:	April 24, 2008
Results First Received:	September 25, 2009
Last Updated:	September 21, 2012
Health Authority:	United States: Institutional Review Board

To Top