Design and Validation of a New Assessment Tool for Lichen Planopilaris, the Boston Grade of Activity in Lichen Planopilaris (Boston GOAL)

Massachusetts General Hospital1 site in 1 country40 target enrollmentFebruary 10, 2017

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lichen Planopilaris of Scalp
Sponsor: Massachusetts General Hospital
Enrollment: 40
Locations: 1
Primary Endpoint: Boston Grade of Activity in Lichen Planopilaris (Boston GOAL)
Last Updated: 4 years ago

The study's Primary Objective is to design and validate a grading system for objective and accurate assessment of lichen planopilaris.

Secondary Objectives:

To assess change in symptoms such as pain and itch using a Numeric Rating Scale(NRS) scores and quality of life using the Dermatology Life Quality Index (DLQI) scores
To correlate this grading system with patient skin biopsies evaluating disease activity on a microscopic level
To correlate this grading system with digital global photography and trichoscopy

Registry

clinicaltrials.gov

Start Date

February 10, 2017

End Date

December 2022

Last Updated

4 years ago

Study Type

Observational

Sex

All

Sponsor

Responsible Party

Principal Investigator

Maryanne Makredes Senna

Dermatologist

Massachusetts General Hospital

•Male or female subjects in general good health between the ages of 18 and 80 years old
•Clinical and histologic diagnosis of lichen planopilaris
•Subject is able to understand and sign informed consent
•Subject is able to complete the study and comply with study procedures
•Subject has no known allergy to non-toxic ink
•Subjects should be managed by an Massachusetts General Hospital dermatologist for their lichen planopilaris for the duration of the study

•Eligible subjects will be excluded from participation if they meet any of the following criteria:
•Presence of dermatoses that might interfere with LPP diagnosis and/or evaluation such as seborrheic dermatitis or psoriasis
•Other selected concomitant causes of hair loss, including discoid lupus erythematosus, central centrifugal cicatricial alopecia (CCCA), telogen effluvium
•Abnormal TSH laboratory value \>1 standard deviation above normal within last year
•Any significant medical condition that may prevent the patient from participating in the study according to the investigator's assessment
•Any known allergy to non-toxic ink Related to Biopsy
•History of poor wound healing or blood-clotting abnormality
•History of keloid formation or hypertrophic scarring
•Regular intake of high doses of aspirin or anti-coagulant medications
•Hypersensitivity to local anesthetics