Trial Outcomes & Findings for Excimer Light Treatment for Idiopathic Guttate Hypomelanosis: A Pilot Study (NCT NCT01956435)

NCT ID: NCT01956435

Last Updated: 2017-12-02

Results Overview

Effectiveness will be graded by the blinded observer scal via photographic comparisons at the end of the study. Efficacy was assessed by improvement from baseline using the following scale: -1 = Worsening of IGH; 0 = No Improvement (IGH remained stable); 1 = Mild improvement of IGH (some re-pigmentation on \<50% IGH); 2 = Moderate improvement (some re-pigmentation on \>50% or full re-pigmentation on \<75% IGH); 3 = Full re-pigmentation on \>75% IGH.

Recruitment status

COMPLETED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

12 weeks

Results posted on

2017-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	Excimer Light Treatment Right Leg, Control Left Leg Excimer light treatment will be performed on patients randomized to receive treatment on the right leg and left leg will be untreated control	Excimer Light Treatment Left Leg, Control Right Leg Excimer light treatment will be performed on patients randomized to receive treatment on the left leg and right leg will be untreated control
Overall Study STARTED	3	3
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Excimer Light Treatment for Idiopathic Guttate Hypomelanosis: A Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=6 Participants All Study Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: healthy adult patients with bilateral IGH lesions on lower extremities

Outcome measures

Outcome measures
Measure	Excimer Light Treatment n=6 Participants Lesions treated with excimer light	Control n=6 Participants Lesions not treated with excimer light
Efficacy Outcome	2.31 units on a scale Interval 2.08 to 2.54	1.15 units on a scale Interval 0.92 to 1.39

SECONDARY outcome

Timeframe: 12 weeks

Population: healthy adult patients with bilateral IGH lesions on lower extremities

Subject reported level of re-pigmentation for treated lesions was assessed by improvement from baseline using a scale from 1 - 4 with 1 being the least amount of re-pigmentation and 4 being the most re-pigmentation: 1 = Worsening of the light spots that were treated (the light spots seem to have gotten lighter or I have more light spots in the areas that were treated); 2 = No Improvement of the light spots (light spots have not changed since starting this study); 3 = Mild improvement of the light spots (there is some darkening of the light spots, but not in more than half of them); 4 = Moderate improvement (there is some darkening of the light spots in more than half of the light spots, but not more than 75% of them).

Outcome measures

Outcome measures
Measure	Excimer Light Treatment n=6 Participants Lesions treated with excimer light	Control Lesions not treated with excimer light
Subject Self-reported Assessment of Re-pigmentation for Treated Lesions	4.5 units on a scale Standard Deviation 0.223	—

Adverse Events

Excimer Light Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Ammar Ahmed, MD

University of Texas at Austin Medical School and Seton Family of Hospitals

Phone: 512-504-0855

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place