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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
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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

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.

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
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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.

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
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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 ]
  Show Outcome Measure 6

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
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  Other Adverse Events
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  More Information
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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:
unchecked 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.
unchecked 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.


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