Design and Validation of a New Assessment Tool for Lichen... | NCT03082560

Studies
Design and Validation of a New Assessment Tool for Lichen Planopilaris

NCT03082560

Sponsor

Massachusetts General Hospital

Status

Unknown status

Last Update Posted

Jan 26, 2022Actual

Enrollment

40Actual

Phase

Not provided

Conditions

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

Interventions

Boston Grade of Activity in Lichen Planopilaris

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2017Actual

Primary Completion Date

Sep 11, 2020Actual

Completion Date

Dec 2022Estimated

First Submitted Date

Mar 13, 2017

First Submission Date that Met QC Criteria

Mar 13, 2017

First Posted Date

Mar 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2022

Last Update Posted Date

Jan 26, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Healthy adult patients with lichen planopilaris	Diagnostic Test: Boston Grade of Activity in Lichen Planopilaris

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Boston Grade of Activity in Lichen Planopilaris	Diagnostic Test	A clinical assessment tool to objectively and accurately measure activity and severity in lichen planopilaris over time.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy adult subjects with lichen planopilaris

Sampling Method

Non-Probability Sample

ID	Term
D017512	Lichenoid Eruptions
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases