Design and Validation of a New Assessment Tool for Lichen Planopilaris
Status: | Active, not recruiting |
---|---|
Conditions: | Skin and Soft Tissue Infections, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 3/9/2019 |
Start Date: | February 10, 2017 |
End Date: | December 2019 |
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
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
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
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Maryanne Senna, MD
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