Trial Outcomes & Findings for Mechlorethamine Induced Contact Dermatitis Avoidance Study (NCT NCT03380026)

Last Updated: 2021-11-24

Results Overview

Incidence of moderate to severe contact dermatitis in patients treated concurrently with Triamcinolone 0.1% ointment versus those that are not. Dermatitis will be defined as a finding of cutaneous inflammatory reaction occurring as a result of treatment. This will be assessed by the SCORD (SCORing Dermatitis) tool and may be confirmed by biopsy of the specimen. Moderate to Severe Contact dermatitis is defined as \>25 by SCORD.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

4 months

Results posted on

2021-11-24

Participant Flow

Patients presenting to medical clinic eligible for mechlorethamine topical therapy.

Two week wash out. Prior to treatment, one half of each patient's body (divided sagittally at the midline) is assigned to treatment with Valchlor only, while the other side of the patient's body is assigned to treatment with both Valchlor and Triamcinolone Acetonide. Group assignment is determined randomly by the flip of a coin.

Participant milestones

Participant milestones
Measure	All Participants Group consisting of all trial participants that completed screening and randomization. In this split-person study, lesions from one half of each participant's body are assigned to one of two treatment groups: One half of the body is assigned to treatment of affected lesions with Valchlor only, while the other half of the body is assigned to treatment of affected lesions with both Valchlor and Triamcinolone. For the Valchlor only group, Valchlor is applied once nightly to the target lesions. For the Valchlor + Triamcinolone group, 0.016% w/w topical mechlorethamine gel is applied once nightly to target lesions, and Triamcinolone acetonide 0.1% ointment is applied up to three time per day to target lesions over a minimum of 8 cm2 For both groups, the treatment period spanned four months.
Overall Study STARTED	28
Overall Study Half of Body Assigned to Treatment With Valchlor Only	28
Overall Study Half of Body Assigned to Treatment With Valchlor and Triamcinolone Acetonide	28
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mechlorethamine Induced Contact Dermatitis Avoidance Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=28 Participants Group consisting of all trial participants that completed screening and randomization. In this split-person study, lesions from one half of each participant's body are assigned to one of two treatment groups: One half of the body is assigned to treatment of affected lesions with Valchlor only, while the other half of the body is assigned to treatment of affected lesions with both Valchlor and Triamcinolone. For the Valchlor only group, Valchlor is applied once nightly to the target lesions. For the Valchlor + Triamcinolone group, 0.016% w/w topical mechlorethamine gel is applied once nightly to target lesions, and Triamcinolone acetonide 0.1% ointment is applied up to three time per day to target lesions over a minimum of 8 cm2 For both groups, the treatment period spanned four months.
Age, Customized 21-30	2 Participants n=5 Participants
Age, Customized 31-40	1 Participants n=5 Participants
Age, Customized 41-50	2 Participants n=5 Participants
Age, Customized 51-60	6 Participants n=5 Participants
Age, Customized 61-70	7 Participants n=5 Participants
Age, Customized 71-80	7 Participants n=5 Participants
Age, Customized 81-90	3 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	2 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months

Population: Each patient had both treatments (self-controlled)

Outcome measures

Outcome measures
Measure	Valchlor 0.016% Topical Gel n=27 Participants 0.016% w/w topical mechlorethamine gel applied over a minimum of 8 cm2, nightly, over a period of 4 months. Valchlor 0.016 % Topical Gel: Apply valchlor nightly on select lesions.	Valchlor Plus Triamcinolone n=27 Participants 0.016% w/w topical mechlorethamine gel (once, nightly) and Triamcinolone acetonide 0.1% ointment (up to three times daily) applied in over a minimum of 8 cm2, over a period of 4 months. Triamcinolone: Apply up to three times daily on select lesions. Valchlor 0.016 % Topical Gel: Apply valchlor nightly on select lesions.
Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring	16 patients	11 patients

SECONDARY outcome

Timeframe: 4 months

Population: All analyzed trial participants Were included in assessment of dermatitis. 12 incidents of dermatitis were observed across the study, and at each incident a biopsy of the affected area was sent for histopathological review. 10 of 12 patients presented with allergic contact dermatitis, while 2 out of 10 12 patients presented with irritant contact dermatitis according to pathology results.

The presence of allergic versus irritant dermatitis was characterized through skin biopsies sent for pathological review and patch testing. Subjects presenting to the clinic with dermatitis underwent patch testing to determine the presence of allergic vs. Irritant contact dermatitis, and at each case a biopsy sample was taken of the affected area to confirm the diagnosis. Patch testing was assessed by the investigator according to the International Contact Dermatitis Research Group scale, using the following for possible outcomes : ?+ indicates a doubtful reaction, 1+ indicates a weak reaction, 2+ represents a strong reaction, 3+ indicates an extreme reaction, and IR indicates an Irritant reaction. A higher score would indicate a worse outcome. 1-3+ reaction at the 96hr reading was considered positive for allergic contact dermatitis.

Outcome measures

Outcome measures
Measure	Valchlor 0.016% Topical Gel n=12 Incidents of dermatitis 0.016% w/w topical mechlorethamine gel applied over a minimum of 8 cm2, nightly, over a period of 4 months. Valchlor 0.016 % Topical Gel: Apply valchlor nightly on select lesions.	Valchlor Plus Triamcinolone 0.016% w/w topical mechlorethamine gel (once, nightly) and Triamcinolone acetonide 0.1% ointment (up to three times daily) applied in over a minimum of 8 cm2, over a period of 4 months. Triamcinolone: Apply up to three times daily on select lesions. Valchlor 0.016 % Topical Gel: Apply valchlor nightly on select lesions.
Nature of Contact Dermatitis (Allergic Versus Irritant) Incidents of Contact Dermatitis	2 Incidents of dermatitis	—
Nature of Contact Dermatitis (Allergic Versus Irritant) Incidents of Allergic Dermatitis	10 Incidents of dermatitis	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

Scoring Atopic Dermatitis (SCORAD) differences between lesions treated with Valchlor and Triamcinolone versus lesions treated with Valchlor only. SCORAD measures the extent and severity of dermatitis. The percentage of total body surface area (0-100) covered by a lesion is measured by an investigator, and this number corresponds to score "A." The intensity criteria are met by scoring erythema, edema/papulation, oozing/crusting, excoriation, xerosis, and thickness on a scale of 0-3 (0=none, 1=mild, 2=Moderate, 3=Severe). These values are summed to give a total score, "B." Subjective symptoms of pruritus and insomnia are then scored using visual analogue scales ranging from 0-10 (0=none, 10=worst imaginable), and the result of each is summed to give score "C". The final score is then calculated by the formula A/5 + 7B/2 + C. The lowest possible score is 0, and the highest possible score is 103. A higher score indicates a worse outcome. A lower score would be a better outcome.

Outcome measures

Outcome measures
Measure	Valchlor 0.016% Topical Gel n=27 Participants 0.016% w/w topical mechlorethamine gel applied over a minimum of 8 cm2, nightly, over a period of 4 months. Valchlor 0.016 % Topical Gel: Apply valchlor nightly on select lesions.	Valchlor Plus Triamcinolone n=27 Participants 0.016% w/w topical mechlorethamine gel (once, nightly) and Triamcinolone acetonide 0.1% ointment (up to three times daily) applied in over a minimum of 8 cm2, over a period of 4 months. Triamcinolone: Apply up to three times daily on select lesions. Valchlor 0.016 % Topical Gel: Apply valchlor nightly on select lesions.
Severity of Dermatitis	24.8 score on a scale Standard Deviation 21.8	12.7 score on a scale Standard Deviation 13.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

Population: CAILS

Efficacy of Valchlor therapy with Triamcinolone compared to Valchlor using a composite assessment of index lesion severity (CAILS). CAILS is an objective, quantitative, method to assess the extent of skin lesions. Skin lesions and erythema will be evaluated using CAILS. A Composite Assessment will be generated for each time point by a summation of the grades for each index lesion's erythema, scaling, plaque elevation, hypopigmentation or hyperpigmentation, and area of involvement. The index lesion grade at baseline will be divided into the grade at each subsequent study visit to determine the subject's response to treatment. Any ratio of the grade obtained at the visit vs. the one obtained at baseline that is \>1.0 will indicate worsening of disease.

Outcome measures

Outcome measures
Measure	Valchlor 0.016% Topical Gel n=27 Participants 0.016% w/w topical mechlorethamine gel applied over a minimum of 8 cm2, nightly, over a period of 4 months. Valchlor 0.016 % Topical Gel: Apply valchlor nightly on select lesions.	Valchlor Plus Triamcinolone n=27 Participants 0.016% w/w topical mechlorethamine gel (once, nightly) and Triamcinolone acetonide 0.1% ointment (up to three times daily) applied in over a minimum of 8 cm2, over a period of 4 months. Triamcinolone: Apply up to three times daily on select lesions. Valchlor 0.016 % Topical Gel: Apply valchlor nightly on select lesions.
Efficacy of Valchlor vs Valchlor Plus Triamcinolone Average CAILS score at Baseline	8.6 CAILS score Standard Deviation 4.2	7.0 CAILS score Standard Deviation 5.1
Efficacy of Valchlor vs Valchlor Plus Triamcinolone Average CAILS score at Month 4	11.4 CAILS score Standard Deviation 4.9	12.0 CAILS score Standard Deviation 4.85

Adverse Events

Valchlor 0.016% Topical Gel

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Valchlor Plus Triamcinolone

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	Valchlor 0.016% Topical Gel n=28 participants at risk 0.016% w/w topical mechlorethamine gel applied over a minimum of 8 cm2, nightly, over a period of 4 months. Valchlor 0.016 % Topical Gel: Apply valchlor nightly on select lesions.	Valchlor Plus Triamcinolone n=28 participants at risk 0.016% w/w topical mechlorethamine gel (once, nightly) and Triamcinolone acetonide 0.1% ointment (up to three times daily) applied in over a minimum of 8 cm2, over a period of 4 months. Triamcinolone: Apply up to three times daily on select lesions. Valchlor 0.016 % Topical Gel: Apply valchlor nightly on select lesions.
Skin and subcutaneous tissue disorders Contact Dermatitis	57.1% 16/28 • Number of events 16 • 12 months	39.3% 11/28 • Number of events 11 • 12 months

Additional Information

Clinical Research Coordinator

Rochester Skin Lymphoma Medical Group

Phone: (585)364-1188

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place