Trial Outcomes & Findings for A New Micrografting Technique for Vitiligo (NCT NCT01262547)

NCT ID: NCT01262547

Last Updated: 2014-10-31

Results Overview

Target Vitiligo Area Scoring Index (VASI) consists of a 7-point scale ranging from 0 (no change in depigmentation) to 6 (complete repigmentation).

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2014-10-31

Participant Flow

Participant milestones

Measure	Patients With Vitiligo Three subjects with vitiligo were recruited for the study. All subjects had three test sites that were studied. One site received dermabrasion and micrografting, one site received dermabrasion alone and one site was not treated and served as the control.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A New Micrografting Technique for Vitiligo

Baseline characteristics by cohort

Measure	All Study Participants n=3 Participants Dermabrasion-Micrografting, Dermabrasion and Control Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis). Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline. Control: Untreated depigmented area
Age, Continuous	47 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Target Vitiligo Area Scoring Index (VASI) consists of a 7-point scale ranging from 0 (no change in depigmentation) to 6 (complete repigmentation).

Outcome measures

Measure	Dermabrasion-Micrografting n=3 Participants Dermabrasion-Micrografting Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis).	Dermabrasion Alone n=3 Participants Dermabrasion alone Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline.	Control n=3 Participants Target sites did not receive any treatment
Change in Target VASI Score From Baseline to Week 24.	0.33 units on a scale Interval 0.0 to 1.0	0.33 units on a scale Interval 0.0 to 1.0	0 units on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Measure	Dermabrasion-Micrografting n=3 Participants Dermabrasion-Micrografting Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis).	Dermabrasion Alone n=3 Participants Dermabrasion alone Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline.	Control n=3 Participants Target sites did not receive any treatment
Incidence of Adverse Effects, Including Increased Activity of Vitiligo	2 participants reporting redness	2 participants reporting redness	0 participants reporting redness

Adverse Events

Dermabrasion-Micrografting

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Dermabrasion Alone

Serious events: 0 serious events

Other events: 2 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

Measure	Dermabrasion-Micrografting n=3 participants at risk Dermabrasion-Micrografting Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis).	Dermabrasion Alone n=3 participants at risk Dermabrasion alone Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline.	Control n=3 participants at risk Control Depigmented areas that did not receive any treatment.
Skin and subcutaneous tissue disorders Mild Redness	33.3% 1/3 • Number of events 1 • 24 Weeks	33.3% 1/3 • Number of events 1 • 24 Weeks	0.00% 0/3 • 24 Weeks
Skin and subcutaneous tissue disorders Moderate Redness	33.3% 1/3 • Number of events 1 • 24 Weeks	33.3% 1/3 • Number of events 1 • 24 Weeks	0.00% 0/3 • 24 Weeks

Additional Information

Dr. Alexandra Kimball

Massachusetts General Hospital

Phone: 617-726-5066

Email: harvardskinstudies@partners.org

Results disclosure agreements

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