Trial Outcomes & Findings for Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks (NCT NCT00585247)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

8 weeks baseline

Results posted on

2022-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	Imiquimod 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)	Placebo 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)
Overall Study STARTED	14	13
Overall Study COMPLETED	14	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Imiquimod n=14 Participants 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.	Placebo n=13 Participants 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 n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks baseline

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.

Outcome measures

Outcome measures
Measure	Imiquimod n=14 Participants 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	Placebo n=13 Participants 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
Change From Baseline in a* and E at 8 Weeks a*	1.27 units on a scale Standard Deviation 1.76	0.43 units on a scale Standard Deviation 1.63
Change From Baseline in a* and E at 8 Weeks ΔE	4.08 units on a scale Standard Deviation 3.39	2.59 units on a scale Standard Deviation 1.54

Adverse Events

Imiquimod

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dr. Kristen Kelly

University of Ccalifornia, Irvine. Beckman Laser Institute

Phone: 949.824.7997

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place