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Trial record 18 of 32 for:    Stain | "Parkes Weber syndrome" OR "Vascular Malformations"

Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks (Aldara)

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ClinicalTrials.gov Identifier: NCT00585247
Recruitment Status : Completed
First Posted : January 3, 2008
Results First Posted : April 4, 2018
Last Update Posted : April 4, 2018
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Port Wine Stain
Interventions Drug: Imiquimod
Other: Placebo
Enrollment 27

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Imiquimod Placebo
Hide Arm/Group Description

Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Imiquimod: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Healthy individuals with PWS (n = 14) were treated with PDL and then randomized to apply post treatment Imiquimod 5% cream for 8 weeks for 57 PWS sites (multiple sites per patient)

Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Placebo: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Healthy individuals with PWS (n = 13) were treated with PDL and then randomized to apply post treatment placebo cream for 8 weeks for 57 PWS sites (multiple sites per patient)

Period Title: Overall Study
Started 14 13
Completed 14 13
Not Completed 0 0
Arm/Group Title Imiquimod Placebo Total
Hide Arm/Group Description

Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Imiquimod: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks were treated with PDL and then randomized to apply post treatment imiquimod 5% cream for 8 weeks.

Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Placebo: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks were treated with PDL and then randomized to apply post treatment placebo cream for 8 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 14 13 27
Hide Baseline Analysis Population Description
27 subjects was enrolled to the study for 57 PWS sites (multiple sites per patient).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
<=18 years
4
  28.6%
0
   0.0%
4
  14.8%
Between 18 and 65 years
9
  64.3%
13
 100.0%
22
  81.5%
>=65 years
1
   7.1%
0
   0.0%
1
   3.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
Female
7
  50.0%
6
  46.2%
13
  48.1%
Male
7
  50.0%
7
  53.8%
14
  51.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 13 participants 27 participants
14 13 27
1.Primary Outcome
Title Change From Baseline in a* and E at 8 Weeks
Hide Description Change in a* and ΔE is a way to quantify PWS treatment outcome: a* is the erythema of the vascular lesions and varies from +60 for green to −60 for red with a value of +9.28 for Normal Skin. Higher a* values indicates a greater reduction in erythema hence better treatment outcome. ΔE detects all three dimensions of colorspace (L*a*b*) and represents the difference in color between normal and PWS skin. Range of ΔE is 0 to 100. Higher values indicates improved treatment efficacy by greater skin color improvement.
Time Frame 8 weeks baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Imiquimod Placebo
Hide Arm/Group Description:

Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Imiquimod: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Placebo: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
a* 1.27  (1.76) 0.43  (1.63)
ΔE 4.08  (3.39) 2.59  (1.54)
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Imiquimod Placebo
Hide Arm/Group Description

Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Imiquimod: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Healthy individuals with PWS (n = 24) were treated with PDL and then randomized to apply post treatment Imiquimod 5% cream for 8 weeks for 57 PWS sites (multiple sites per patient)

Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Placebo: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Healthy individuals with PWS (n = 24) were treated with PDL and then randomized to apply post treatment placebo cream for 8 weeks for 57 PWS sites (multiple sites per patient)

All-Cause Mortality
Imiquimod Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Imiquimod Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Imiquimod Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/13 (0.00%) 
Effects were evaluated after a single treatment and duration of effect is unknown
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Kristen Kelly
Organization: University of Ccalifornia, Irvine. Beckman Laser Institute
Phone: 949.824.7997
Responsible Party: Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00585247     History of Changes
Other Study ID Numbers: NIH-LAMMP-2006-4815
First Submitted: December 18, 2007
First Posted: January 3, 2008
Results First Submitted: August 25, 2015
Results First Posted: April 4, 2018
Last Update Posted: April 4, 2018