Trial Outcomes & Findings for Personalized Interactive Laser Therapy of Port Wine Stain (NCT NCT00782483)

NCT ID: NCT00782483

Last Updated: 2014-07-21

Results Overview

6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

Three treatments up to one year, whichever is first

Results posted on

2014-07-21

Participant Flow

Participant milestones

Participant milestones
Measure
Laser Therapy
Total number of participants
Overall Study
STARTED
6
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
6

Reasons for withdrawal

Reasons for withdrawal
Measure
Laser Therapy
Total number of participants
Overall Study
Early Termination of Protocol - PI Reloc
6

Baseline Characteristics

Personalized Interactive Laser Therapy of Port Wine Stain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall
n=6 Participants
Overall Study Group
Age, Categorical
<=18 years
1 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
5 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
Region of Enrollment
United States
6 participants
n=5 Participants

PRIMARY outcome

Timeframe: Three treatments up to one year, whichever is first

Population: 6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.

6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.

Outcome measures

Outcome data not reported

Adverse Events

Overall

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. Gal Shafirstein

University of Arkansas for Medical Sciences/Arkansas Children's Hospital

Phone: 501-364-7546

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place