Clinical trial NCT03082560: Design and Validation of a New Assessment Tool for Lichen Planopilaris
Official title: Design and Validation of a New Assessment Tool for Lichen Planopilaris, the Boston Grade of Activity in Lichen Planopilaris (Boston GOAL)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lichen Planopilaris of Scalp
Lichen Plano-Pilaris
Lichen Planopilaris
Frontal Fibrosing Alopecia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult subjects with lichen planopilaris

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Eligible subjects will be excluded from participation if they meet any of the following criteria:

1. Presence of dermatoses that might interfere with LPP diagnosis and/or evaluation such as seborrheic dermatitis or psoriasis
2. Other selected concomitant causes of hair loss, including discoid lupus erythematosus, central centrifugal cicatricial alopecia (CCCA), telogen effluvium
3. Abnormal TSH laboratory value \>1 standard deviation above normal within last year
4. Any significant medical condition that may prevent the patient from participating in the study according to the investigator's assessment
5. Any known allergy to non-toxic ink Related to Biopsy
6. History of poor wound healing or blood-clotting abnormality
7. History of keloid formation or hypertrophic scarring
8. Regular intake of high doses of aspirin or anti-coagulant medications
9. Hypersensitivity to local anesthetics
10. History of poorly controlled diabetes mellitus
11. Pregnant, nursing or planning a pregnancy

Primary outcomes:
measure: Boston Grade of Activity in Lichen Planopilaris (Boston GOAL)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Maryanne Senna, MD
role: PRINCIPAL_INVESTIGATOR
References: