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Design and Validation of a New Assessment Tool for Lichen Planopilaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03082560
Recruitment Status : Active, not recruiting
First Posted : March 17, 2017
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Maryanne Makredes Senna, Massachusetts General Hospital

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
Lichen Planopilaris of Scalp Lichen Plano-Pilaris Lichen Planopilaris Frontal Fibrosing Alopecia Diagnostic Test: Boston Grade of Activity in Lichen Planopilaris

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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 : February 10, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019


Group/Cohort 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.




Primary Outcome Measures :
  1. Boston Grade of Activity in Lichen Planopilaris (Boston GOAL) [ Time Frame: 6 months ]
    Design and validate a grading system for objective and accurate assessment of lichen planopilaris.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Healthy adult subjects with lichen planopilaris
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03082560


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Maryanne Senna, MD Massachusetts General Hospital

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Responsible Party: Maryanne Makredes Senna, Dermatologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03082560     History of Changes
Other Study ID Numbers: 2016P002620
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Alopecia
Lichen Planus
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Lichenoid Eruptions
Skin Diseases, Papulosquamous