NCT03417141

Valchlor in the Treatment of Lichen Planopilaris

Completed Phase 2 Results posted Last updated 28 January 2021

What this trial tests

Phase 2 trial testing Mechlorethamine 0.016% Top Gel in Lichen Planopilaris in 12 participants. Completed in 30 August 2019.

Timeline

1 April 2018

Primary endpoint
30 August 2019

30 August 2019

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 April 2018
Primary completion	30 August 2019
Estimated completion	30 August 2019
Sites	1 location across United States

Drugs / interventions tested

• Mechlorethamine 0.016% Top Gel — full drug profile →

Conditions studied

• Lichen Planopilaris — all drugs for Lichen Planopilaris →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Lichen Planopilaris. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Lichen Planopilaris Activity Index (LLPAI) Primary · baseline, up to 24 weeks

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.

Week 12

Group	Value	95% CI
Valchor Treatment of Lichen Planopilaris	-42.9	-100.0 – 33.3

Week 24

Group	Value	95% CI
Valchor Treatment of Lichen Planopilaris	-66.7	-100.0 – 66.7

Change in Dermatology Quality of Life Index (DQLI) Secondary · baseline, 24 weeks

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

Group	Value	95% CI
Valchor Treatment of Lichen Planopilaris	-2	-11 – 2

Change in Follicular Units Secondary · baseline, 24 weeks

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.

Group	Value	95% CI
Valchor Treatment of Lichen Planopilaris	-9.1	-25.8 – 37.5

Change in Mean Follicular Density Secondary · baseline, 24 weeks

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.

Group	Value	95% CI
Valchor Treatment of Lichen Planopilaris	-9.0	-25.8 – 37.6

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collect for each subject from baseline until last treatment for a total of approximately six months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Valchor Treatment of Lichen Planopilaris

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (2 terms — click to expand)

Reaction	System	Valchor Treatment of Liche…
Contact dermatitis	Skin and subcutaneous tissue disorders	—
Severe Itching	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT03417141 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Lichen Planus.
   Boch K, Langan EA, Kridin K, Zillikens D, et al · · 2021 · cited 84× · PMID 34790675 · DOI 10.3389/fmed.2021.737813