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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

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.

Condition or disease Intervention/treatment Phase
Lichen Planopilaris Drug: Valchlor Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
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
Official Title: Valchlor in the Treatment of Lichen Planopilaris: A Single Arm, Open- Label, Exploratory Study
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : August 30, 2019
Actual Study Completion Date : August 30, 2019


Arm Intervention/treatment
Experimental: Valchor treatment of Lichen Planopilaris
Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.
Drug: Valchlor
Valchlor, a 0.016% gel formulation of mechlorethamine. Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03417141


Locations
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Actelion
Investigators
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Principal Investigator: Jason Sluzevich, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Jason Sluzevich MD, Mayo Clinic:
Additional Information:
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Responsible Party: Jason Sluzevich MD, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03417141    
Other Study ID Numbers: IRB 16-006731
First Posted: January 31, 2018    Key Record Dates
Results First Posted: July 2, 2020
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jason Sluzevich MD, Mayo Clinic:
Valchor
Additional relevant MeSH terms:
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Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mechlorethamine
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Antineoplastic Agents