Design and Validation of a New Assessment Tool for Lichen Planopilaris

NCT03082560 | Unknown

• 1 other identifier: 2016P002620
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Lichen Planopilaris of Scalp; Lichen Planopilaris; Frontal Fibrosing Alopecia

Outcome Measures

Primary Outcomes (1)

• Boston Grade of Activity in Lichen Planopilaris (Boston GOAL)

  Design and validate a grading system for objective and accurate assessment of lichen planopilaris.

  6 months

Study Arms (1)

Group 1

Healthy adult patients with lichen planopilaris

Diagnostic Test: Boston Grade of Activity in Lichen Planopilaris

Interventions

Boston Grade of Activity in Lichen Planopilaris DIAGNOSTIC_TEST

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

Group 1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult subjects with lichen planopilaris

You may qualify if:

• 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

You may not qualify if:

• 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
• History of poorly controlled diabetes mellitus
• Pregnant, nursing or planning a pregnancy

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Lichen Planus

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Maryanne Senna, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 17, 2017
• Study Start: February 10, 2017
• Primary Completion: September 11, 2020
• Study Completion: December 1, 2022
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)