Design and Validation of a New Assessment Tool for Lichen Planopilaris

NCT ID: NCT03082560

Last Updated: 2022-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-10
• Study Completion Date: 2022-12-31

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 Plano-Pilaris; Lichen Planopilaris; Frontal Fibrosing Alopecia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Healthy adult patients with lichen planopilaris

Boston Grade of Activity in Lichen Planopilaris

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Boston Grade of Activity in Lichen Planopilaris

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Maryanne Makredes Senna

Dermatologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maryanne Senna, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2016P002620

Identifier Type: -

Identifier Source: org_study_id