Lichen Planopilaris of ScalpNCT03082560
Design and Validation of a New Assessment Tool for Lichen Planopilaris
An observational study of Lichen Planopilaris of Scalp and Lichen Plano-Pilaris, run by Massachusetts General Hospital at 1 site in United States.
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)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lichen Planopilaris of Scalp, Lichen Plano-Pilaris, Lichen Planopilaris
- What is being tested?
- Boston Grade of Activity in Lichen Planopilaris
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2017to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthy adult subjects with lichen planopilaris
Who may be able to join
- 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
Who cannot join
- Eligible subjects will be excluded from participation if they meet any of the following criteria:
- 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
Show all 12Show fewer
- 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
- Hypersensitivity to local anesthetics
- History of poorly controlled diabetes mellitus
- Pregnant, nursing or planning a pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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
- Conditions
- Lichen Planopilaris of Scalp, Lichen Plano-Pilaris, Lichen Planopilaris, Frontal Fibrosing Alopecia
- Being tested
- Boston Grade of Activity in Lichen Planopilaris
- Medical subject headings
- Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boston Grade of Activity in Lichen PlanopilarisDiagnostic test
A clinical assessment tool to objectively and accurately measure activity and severity in lichen planopilaris over time.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Healthy adult patients with lichen planopilaris Receives: Diagnostic Test: Boston Grade of Activity in Lichen Planopilaris |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Grade of Activity in Lichen Planopilaris (Boston GOAL)
Design and validate a grading system for objective and accurate assessment of lichen planopilaris.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start10 Feb 2017
- Primary completion11 Sep 2020
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen Planopilaris of ScalpStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryanne Makredes Senna, Massachusetts General Hospital
- Investigators
- Maryanne Senna, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082560
- Sponsor's protocol ID
- 2016P002620
- Status last verified
- Jan 2022
- First submitted
- 13 Mar 2017
- Last updated
- 26 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Validation of a New Assessment Tool for Lichen Planopilaris, the Boston Grade of Activity in Lichen Planopilaris (Boston GOAL)
- ClinicalTrials.gov ID
- NCT03082560
- Acronym / sponsor ID
- 2016P002620
- Conditions
- Lichen Planopilaris of Scalp, Lichen Plano-Pilaris, Lichen Planopilaris, Frontal Fibrosing Alopecia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 11 Sep 2020 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Boston Grade of Activity in Lichen PlanopilarisHealthy adult patients with lichen planopilaris |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult subjects with lichen planopilaris
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- Eligible subjects will be excluded from participation if they meet any of the following criteria:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boston Grade of Activity in Lichen PlanopilarisA clinical assessment tool to objectively and accurately measure activity and severity in lichen planopilaris over time. | Diagnostic test | Group 1 |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryanne Senna, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lichen Planopilaris of Scalp and Lichen Plano-Pilaris, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Grade of Activity in Lichen Planopilaris (Boston GOAL) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.