Phase 2
N=12
Valchlor in the Treatment of Lichen Planopilaris
Lichen Planopilaris
Bottom Line
View on ClinicalTrials.gov: NCT03417141 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Change in Lichen Planopilaris Activity Index (LLPAI) — -42.9; -66.7 percentage of change from baseline — p=0.014
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mechlorethamine 0.016% Top Gel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Lichen Planopilaris Activity Index (LLPAI) |
-42.9; -66.7 | 0.014 sig |
| SECONDARY Change in Dermatology Quality of Life Index (DQLI) |
-2 | 0.093 |
| SECONDARY Change in Follicular Units |
-9.1 | 0.57 |
| SECONDARY Change in Mean Follicular Density |
-9.0 | 0.55 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03417141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.