Valchlor in the Treatment of Lichen Planopilaris

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.

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