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Design and Validation of a New Assessment Tool for Lichen Planopilaris

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03082560
Collaborator
(none)
40
Enrollment
1
Location
69.7
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Boston Grade of Activity in Lichen Planopilaris

Study Design

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Design and Validation of a New Assessment Tool for Lichen Planopilaris, the Boston Grade of Activity in Lichen Planopilaris (Boston GOAL)
Actual Study Start Date :
Feb 10, 2017
Actual Primary Completion Date :
Sep 11, 2020
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maryanne Makredes Senna, Dermatologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT03082560
Other Study ID Numbers:
  • 2016P002620
First Posted:
Mar 17, 2017
Last Update Posted:
Jan 26, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Alopecia
Lichen Planus

Study Results

No Results Posted as of Jan 26, 2022