Valchlor in the Treatment of Lichen Planopilaris

Lichen Planopilaris Clinical Trial

Official title:

Valchlor in the Treatment of Lichen Planopilaris: A Single Arm, Open- Label, Exploratory Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03417141
• Other study ID #: IRB 16-006731
• Status: Completed
• Phase: Phase 2
• Start date: April 1, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: January 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lichen Planopilaris
• Lichen Planus

Intervention

Drug:
• Mechlorethamine 0.016% Top Gel
Valchlor, a 0.016% gel formulation of mechlorethamine. Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Actelion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Lichen Planopilaris Activity Index (LLPAI)	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.	baseline, up to 24 weeks
Secondary	Change in Dermatology Quality of Life Index (DQLI)	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	baseline, 24 weeks
Secondary	Change in Follicular Units	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.	baseline, 24 weeks
Secondary	Change in Mean Follicular Density	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.	baseline, 24 weeks

External Links

•   Mayo Clinic Clinical Trials