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Design and Validation of a New Assessment Tool for Lichen Planopilaris

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03082560
Enrollment
40
Registered
2017-03-17
Start date
2017-02-10
Completion date
2022-12-31
Last updated
2022-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frontal Fibrosing Alopecia, Lichen Planopilaris, Lichen Plano-Pilaris, Lichen Planopilaris of Scalp

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

Interventions

DIAGNOSTIC_TESTBoston Grade of Activity in Lichen Planopilaris

A clinical assessment tool to objectively and accurately measure activity and severity in lichen planopilaris over time.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Boston Grade of Activity in Lichen Planopilaris (Boston GOAL)6 monthsDesign and validate a grading system for objective and accurate assessment of lichen planopilaris.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026