Trial Outcomes & Findings for Valchlor in the Treatment of Lichen Planopilaris (NCT NCT03417141)

Last Updated: 2021-01-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

baseline, up to 24 weeks

Results posted on

2021-01-28

Participant Flow

Participant milestones

Participant milestones
Measure	Valchor Treatment of Lichen Planopilaris Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris. Valchlor: Valchlor, a 0.016% gel formulation of mechlorethamine. Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.
Overall Study STARTED	12
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Valchor Treatment of Lichen Planopilaris Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris. Valchlor: Valchlor, a 0.016% gel formulation of mechlorethamine. Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	3

Baseline Characteristics

Valchlor in the Treatment of Lichen Planopilaris

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Valchor Treatment of Lichen Planopilaris n=12 Participants Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris. Valchlor: Valchlor, a 0.016% gel formulation of mechlorethamine. Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
LICHEN PLANOPILARIS ACTIVITY INDEX (LPPAI)	5 Integer n=5 Participants

PRIMARY outcome

Timeframe: baseline, up to 24 weeks

Population: One subject withdrew and data was not analyzed for that subject

Outcome measures

Outcome measures
Measure	Valchor Treatment of Lichen Planopilaris n=11 Participants Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris. Valchlor: Valchlor, a 0.016% gel formulation of mechlorethamine. Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.
Change in Lichen Planopilaris Activity Index (LLPAI) Week 12	-42.9 percentage of change from baseline Interval -100.0 to 33.3
Change in Lichen Planopilaris Activity Index (LLPAI) Week 24	-66.7 percentage of change from baseline Interval -100.0 to 66.7

SECONDARY outcome

Timeframe: baseline, 24 weeks

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

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

Outcome measures

Outcome measures
Measure	Valchor Treatment of Lichen Planopilaris n=8 Participants Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris. Valchlor: Valchlor, a 0.016% gel formulation of mechlorethamine. Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.
Change in Dermatology Quality of Life Index (DQLI)	-2 score on a scale Interval -11.0 to 2.0

SECONDARY outcome

Timeframe: baseline, 24 weeks

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

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.

Outcome measures

Outcome measures
Measure	Valchor Treatment of Lichen Planopilaris n=8 Participants Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris. Valchlor: Valchlor, a 0.016% gel formulation of mechlorethamine. Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.
Change in Follicular Units	-9.1 percent change Interval -25.8 to 37.5

SECONDARY outcome

Timeframe: baseline, 24 weeks

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

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.

Outcome measures

Outcome measures
Measure	Valchor Treatment of Lichen Planopilaris n=8 Participants Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris. Valchlor: Valchlor, a 0.016% gel formulation of mechlorethamine. Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.
Change in Mean Follicular Density	-9.0 percent change Interval -25.8 to 37.6

Adverse Events

Valchor Treatment of Lichen Planopilaris

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Valchor Treatment of Lichen Planopilaris n=12 participants at risk Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris. Valchlor: Valchlor, a 0.016% gel formulation of mechlorethamine. Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.
Skin and subcutaneous tissue disorders Contact dermatitis	91.7% 11/12 • Number of events 11 • Adverse events were collect for each subject from baseline until last treatment for a total of approximately six months
Skin and subcutaneous tissue disorders Severe Itching	8.3% 1/12 • Number of events 1 • Adverse events were collect for each subject from baseline until last treatment for a total of approximately six months

Additional Information

Jason C. Sluzevich, M.D.

Mayo Clinic

Phone: 904-953-6192

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place