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)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Frontal Fibrosing Alopecia; Lichen Planopilaris; Lichen Planopilaris of Scalp; Lichen Plano-Pilaris
• Intervention / Treatment: Diagnostic test: Boston Grade of Activity in Lichen Planopilaris

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy adult subjects with lichen planopilaris

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Healthy adult patients with lichen planopilaris	Diagnostic test: Boston Grade of Activity in Lichen Planopilaris; A clinical assessment tool to objectively and accurately measure activity and severity in lichen planopilaris over time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Maryanne Senna, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2017
• Primary Completion (Actual): September 11, 2020
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 13, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (Actual): March 17, 2017

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Skin Diseases, Papulosquamous; Hypotrichosis; Hair Diseases; Lichenoid Eruptions; Alopecia; Lichen Planus
• Other Study ID Numbers: 2016P002620

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No