Valchlor in the Treatment of Lichen Planopilaris

NCT03417141 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB 16-006731
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Lichen Planopilaris

Keywords

Valchor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Dermatology Quality of Life Index (DQLI)

  baseline, 24 weeks

• Change in Follicular Units

  baseline, 24 weeks

• Change in Mean Follicular Density

  baseline, 24 weeks

Study Arms (1)

Valchor treatment of Lichen Planopilaris

EXPERIMENTAL

Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.

Drug: Mechlorethamine 0.016% Top Gel

Interventions

Mechlorethamine 0.016% Top Gel DRUG

Valchlor, a 0.016% gel formulation of mechlorethamine. Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.

Also known as: Valchlor

Valchor treatment of Lichen Planopilaris

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Actelion: collaborator

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Lichen Planus

Interventions

Mechlorethamine; Amines

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals

Limitations and Caveats

One subject withdrew and three subjects were non-compliant with study procedures. Data was not analyzed for a total of four subjects.

Results Point of Contact

• Title: Jason C. Sluzevich, M.D.
• Organization: Mayo Clinic

Sluzevich.Jason@mayo.edu

904-953-6192

Study Officials

• Jason Sluzevich, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Adults patient with active Lichen Planopilaris or Frontal Fibrosing Alopecia

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 31, 2018
• Study Start: April 1, 2018
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: January 28, 2021
• Results First Posted: July 2, 2020

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)