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Trial record 1 of 1 for:    Valchlor in the Treatment of Lichen Planopilaris
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Valchlor in the Treatment of 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: NCT03417141
Recruitment Status : Completed
First Posted : January 31, 2018
Results First Posted : July 2, 2020
Last Update Posted : July 2, 2020
Sponsor:
Collaborator:
Actelion
Information provided by (Responsible Party):
Jason Sluzevich MD, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE January 8, 2018
First Posted Date  ICMJE January 31, 2018
Results First Submitted Date  ICMJE June 1, 2020
Results First Posted Date  ICMJE July 2, 2020
Last Update Posted Date July 2, 2020
Actual Study Start Date  ICMJE April 1, 2018
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2020)
Change in Lichen Planopilaris Activity Index (LLPAI) [ Time Frame: baseline, up to 24 weeks ]
The Lichen Planopilaris Activity Index is a standardized validated quantitative measure of disease activity. LPPAI score (0-10) is calculated as follows: (pruritus + pain + burning)/3 + (scalp erythema + perifollicular erythema + perifollicular scale)/3 + 2.5 (pull test) + 1.5 (spreading/2). Symptoms and signs are graded on a 4-point scale with 0 = absent, 1 = mild, 2 = moderate, and 3 =severe. Clinical progression and a positive hair pull test are graded 1=yes; 0=no. The percent change of LLPAI score from before and after treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
Lichen Planopilaris Activity Index (LLPAI) [ Time Frame: Six months ]
Change of LLPAI score before and after treatment. The Lichen Planopilaris Activity Index is a standardized validated quantitative measure of disease activity. LPPAI score (0-10) is calculated as follows: (pruritus + pain + burning)/3 + (scalp erythema + perifollicular erythema + perifollicular scale)/3 + 2.5 (pull test) + 1.5 (spreading/2). Symptoms and signs are graded on a 4-point scale with 0 = absent, 1 = mild, 2 = moderate, and 3 =severe. Clinical progression and a positive hair pull test are graded 1=yes; 0=no.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2020)
  • Change in Dermatology Quality of Life Index (DQLI) [ Time Frame: baseline, 24 weeks ]
    The DQLI is 10 standardized items measuring impact of skin disease rated as 0=not at all/not relevant; 1=a little; 2=a lot; 3=very much. The absolute change of total DQLI score from before and after treatment
  • Change in Follicular Units [ Time Frame: baseline, 24 weeks ]
    Phototrichograms of all subjects scalps performed using FotoFinder video-epiluminescence microscopy (FotoFinder Systems GmbH) in combination with TrichoScan digital image analysis (TRICHOLOG GmbH and DatInf mbH). The percent change in the total number of hairs per square cm was measured before and after treatment.
  • Change in Mean Follicular Density [ Time Frame: baseline, 24 weeks ]
    Phototrichograms of all subjects scalps performed using FotoFinder video-epiluminescence microscopy (FotoFinder Systems GmbH) in combination with TrichoScan digital image analysis (TRICHOLOG GmbH and DatInf mbH). The percent change in the mean number of follicular units per square cm was measured before and after treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
  • Dermatology Quality of Life Index (DQLI) [ Time Frame: Six months ]
    Change of DQLI score before and after treatment. 10 standardized items measuring impact of skin disease rated as 0=not at all/not relevant; 1=a little; 2=a lot; 3=very much
  • Physician Global Assessment (PGA) [ Time Frame: Six months ]
    Change of PGA score before and after treatment. using standardized photography compared to the presenting baseline and scored as -1 = worse (no change to erythema with new areas of alopecia); 0 = no change; 1 = mild improvement (slight reduction in erythema, alopecia not progressive); 2= moderate (moderate reduction in erythema, alopecia not progressive); 3 = significant improvement (very mild erythema, alopecia not progressive); 4 = clear (no erythema, alopecia not progressive)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Valchlor in the Treatment of Lichen Planopilaris
Official Title  ICMJE Valchlor in the Treatment of Lichen Planopilaris: A Single Arm, Open- Label, Exploratory Study
Brief Summary The primary objective of this study is to assess the potential effectiveness of once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris. The primary measurement of efficacy will be with the Lichen Planopilaris Activity Index (LPPAI) before and after 6 months of treatment. Secondary measures of efficacy will be the mean follicular density, Physician Global assessment (PGA) score, and the Dermatology Quality of Life Index (DQLI) score before and after six months of therapy.
Detailed Description

This is a single arm, open label, exploratory study to evaluate the efficacy of Valchlor in the treatment of LPP. Subjects will be screened by the Department of Dermatology at the Mayo Clinic in Florida outpatient clinic and interested qualified subjects will be consented and offered participation. This study is designed to establish feasibility and proof of concept and will not include randomization or crossover components.

Patients with biopsy proven LPP who have failed one prior topical or systemic therapy with evidence of active disease will be eligible to participate. The presence of active disease will be based on a baseline clinical exam showing perifollicular erythema with scaling. Patients with predominance of end stage scarring hair loss but without significant active erythema will be excluded. Involvement restricted to the frontal scalp is a recognized clinical variant of LPP and is known as frontal fibrosing alopecia (FAA). As the histological features of LPP and FAA are identical, patients with FAA subtype of LPP would also be eligible to participate in the study.

Eligible participants using high-potency topical corticosteroids, intralesional corticosteroids, or oral hydroxychloroquine may enroll but will be required to discontinue use during the study period.

All study participants will apply Valchlor 0.016% gel to involved areas at night. Patients will be instructed to first part the hair away from involved area as needed, limit application to areas with alopecia and erythema, apply 30 minutes after showering or washing, and allow treated areas to dry for 5 to 10 minutes before covering with clothing or going to bed. Participants will be instructed to wash their hands with soap and water after applying Valchlor. Caregivers who assist in application will be instruction to wear disposable nitrile gloves when applying Valchlor and dispose with the household trash. Patients will be instructed to store Valchlor in the refrigerator away from foods at 36°F - 46°F and apply within 30 minutes after removing from refrigeration.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Adults patient with active Lichen Planopilaris or Frontal Fibrosing Alopecia
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lichen Planopilaris
Intervention  ICMJE Drug: Valchlor
Valchlor, a 0.016% gel formulation of mechlorethamine. Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.
Study Arms  ICMJE Experimental: Valchor treatment of Lichen Planopilaris
Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.
Intervention: Drug: Valchlor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 1, 2020)
12
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2018)
10
Actual Study Completion Date  ICMJE August 30, 2019
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female patients 18 years or older.
  • Biopsy proven diagnosis of Lichen Planopilaris
  • Biopsy proven diagnosis of Fontal Fibrosing Alopecia (a clinical variant of LPP restricted to frontal scalp)
  • Good general health as confirmed by medical history
  • Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
  • Patients who read and sign an approved informed consent for this study

Exclusion Criteria:

  • Vulnerable study population
  • Pregnant or nursing women
  • Women planning a pregnancy within the study period
  • Active smokers
  • Known history of adverse reaction to mechlorethamine
  • Use of systemic immunosuppressive
  • Presence of ulcerated scalp lesions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03417141
Other Study ID Numbers  ICMJE IRB 16-006731
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jason Sluzevich MD, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Actelion
Investigators  ICMJE
Principal Investigator: Jason Sluzevich, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP