Design and Validation of a New Assessment Tool for Lichen Planopilaris

Frontal Fibrosing Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03082560
• Other study ID #: 2016P002620
• Status: Active, not recruiting
• Start date: February 10, 2017
• Est. completion date: December 2022

Study information

• Verified date: January 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2022
• Est. primary completion date: September 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Frontal Fibrosing Alopecia
• Lichen Plano-Pilaris
• Lichen Planopilaris
• Lichen Planopilaris of Scalp
• Lichen Planus

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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