Design and Validation of a New Assessment Tool for Lichen Planopilaris (NCT03082560) | Clinical Trial Compass
UnknownNot Applicable
Design and Validation of a New Assessment Tool for Lichen Planopilaris
United States40 participantsStarted 2017-02-10
Plain-language 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
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female subjects in general good health between the ages of 18 and 80 years old
. Clinical and histologic diagnosis of lichen planopilaris
. Subject is able to understand and sign informed consent
. Subject is able to complete the study and comply with study procedures
. Subject has no known allergy to non-toxic ink
. Subjects should be managed by an Massachusetts General Hospital dermatologist for their lichen planopilaris for the duration of the study
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Boston Grade of Activity in Lichen Planopilaris (Boston GOAL)
. Presence of dermatoses that might interfere with LPP diagnosis and/or evaluation such as seborrheic dermatitis or psoriasis
. Other selected concomitant causes of hair loss, including discoid lupus erythematosus, central centrifugal cicatricial alopecia (CCCA), telogen effluvium
. Abnormal TSH laboratory value \>1 standard deviation above normal within last year
. Any significant medical condition that may prevent the patient from participating in the study according to the investigator's assessment
. Any known allergy to non-toxic ink Related to Biopsy
. History of poor wound healing or blood-clotting abnormality
. History of keloid formation or hypertrophic scarring
. Regular intake of high doses of aspirin or anti-coagulant medications