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Trial record 1 of 1 for:    Valchlor in the Treatment of Lichen Planopilaris
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Valchlor in the Treatment of Lichen Planopilaris

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ClinicalTrials.gov Identifier: NCT03417141
Recruitment Status : Completed
First Posted : January 31, 2018
Results First Posted : July 2, 2020
Last Update Posted : July 2, 2020
Sponsor:
Collaborator:
Actelion
Information provided by (Responsible Party):
Jason Sluzevich MD, Mayo Clinic

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lichen Planopilaris
Intervention Drug: Valchlor
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Valchor Treatment of Lichen Planopilaris
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 12
Completed 8
Not Completed 4
Reason Not Completed
Withdrawal by Subject             1
Protocol Violation             3
Arm/Group Title Valchor Treatment of Lichen Planopilaris
Hide Arm/Group Description

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 Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants
66
(50 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
12
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
11
  91.7%
More than one race
0
   0.0%
Unknown or Not Reported
1
   8.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Change in Lichen Planopilaris Activity Index (LLPAI)
Hide Description 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.
Time Frame baseline, up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One subject withdrew and data was not analyzed for that subject
Arm/Group Title Valchor Treatment of Lichen Planopilaris
Hide Arm/Group Description:

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 Number of Participants Analyzed 11
Median (Full Range)
Unit of Measure: percentage of change from baseline
Week 12
-42.9
(-100.0 to 33.3)
Week 24
-66.7
(-100.0 to 66.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Valchor Treatment of Lichen Planopilaris
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Valchor Treatment of Lichen Planopilaris
Comments Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Change in Dermatology Quality of Life Index (DQLI)
Hide Description 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
Time Frame baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One subject withdrew and three subjects were non-compliant with study procedures. Data was not analyzed for a total of four subjects.
Arm/Group Title Valchor Treatment of Lichen Planopilaris
Hide Arm/Group Description:

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 Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: score on a scale
-2
(-11 to 2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Valchor Treatment of Lichen Planopilaris
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.093
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Change in Follicular Units
Hide Description 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.
Time Frame baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One subject withdrew, and three subjects were non-compliant with study procedures. Data was not was not analyzed for a total of four subjects.
Arm/Group Title Valchor Treatment of Lichen Planopilaris
Hide Arm/Group Description:

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 Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: percent change
-9.1
(-25.8 to 37.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Valchor Treatment of Lichen Planopilaris
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Change in Mean Follicular Density
Hide Description 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.
Time Frame baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One subject withdrew and three subjects were non-compliant with study procedures. Data was not analyzed for a total of four subjects.
Arm/Group Title Valchor Treatment of Lichen Planopilaris
Hide Arm/Group Description:

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 Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: percent change
-9.0
(-25.8 to 37.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Valchor Treatment of Lichen Planopilaris
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Adverse events were collect for each subject from baseline until last treatment for a total of approximately six months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Valchor Treatment of Lichen Planopilaris
Hide Arm/Group Description

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.

All-Cause Mortality
Valchor Treatment of Lichen Planopilaris
Affected / at Risk (%)
Total   0/12 (0.00%)    
Hide Serious Adverse Events
Valchor Treatment of Lichen Planopilaris
Affected / at Risk (%) # Events
Total   0/12 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Valchor Treatment of Lichen Planopilaris
Affected / at Risk (%) # Events
Total   11/12 (91.67%)    
Skin and subcutaneous tissue disorders   
Contact dermatitis   11/12 (91.67%)  11
Severe Itching   1/12 (8.33%)  1
Indicates events were collected by systematic assessment
One subject withdrew and three subjects were non-compliant with study procedures. Data was not analyzed for a total of four subjects.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jason C. Sluzevich, M.D.
Organization: Mayo Clinic
Phone: 904-953-6192
EMail: Sluzevich.Jason@mayo.edu
Layout table for additonal information
Responsible Party: Jason Sluzevich MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03417141    
Other Study ID Numbers: IRB 16-006731
First Submitted: January 8, 2018
First Posted: January 31, 2018
Results First Submitted: June 1, 2020
Results First Posted: July 2, 2020
Last Update Posted: July 2, 2020