Design and Validation of a New Assessment Tool for Lichen Planopilaris

• Conditions: Lichen Planopilaris of Scalp; Lichen Planopilaris; Frontal Fibrosing Alopecia; Lichen Plano-Pilaris
• Interventions: Diagnostic Test: Boston Grade of Activity in Lichen Planopilaris

• Registration Number: NCT03082560
• Lead Sponsor: Massachusetts General Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-10
• Study First Submitted: 2017-03-13
• Study First Submitted QC: 2017-03-13
• Study First Posted: 2017-03-17
• Primary Completion: 2020-09-11
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-24
• Last Update Posted: 2022-01-26
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Boston Grade of Activity in Lichen Planopilaris	Healthy adult patients with lichen planopilaris

Primary Outcome Measures

Name	Time	Method
Boston Grade of Activity in Lichen Planopilaris (Boston GOAL)	6 months	Design and validate a grading system for objective and accurate assessment of lichen planopilaris.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States