Trial Outcomes & Findings for The Effects of Dupilumab on Allergic Contact Dermatitis (NCT NCT03935971)

NCT ID: NCT03935971

Last Updated: 2026-02-27

Results Overview

The investigator's global assessment is a physician-reported global assessment of disease activity (range 0-4) with 0 being clear and 4 being severe.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE4

Target enrollment

17 participants

Primary outcome timeframe

week 0, week 6, week 12

Results posted on

2026-02-27

Participant Flow

Our IRB protocol was approved to enroll 30 participants but only 17 were enrolled

6 of the 17 subjects enrolled were found ineligible due to not having a strong enough patch test reaction at visit 3

Participant milestones

Participant milestones
Measure	Subjects With Allergic Contact Dermatitis Dupilumab 600 mg/4 mL subcutaneously once, then 300 mg/2 mL every 2 weeks for 10 weeks Dupilumab: See arm/group description
Overall Study STARTED	17
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Subjects With Allergic Contact Dermatitis Dupilumab 600 mg/4 mL subcutaneously once, then 300 mg/2 mL every 2 weeks for 10 weeks Dupilumab: See arm/group description
Overall Study Did not meet inclusion criteria	6
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	3

Baseline Characteristics

The Effects of Dupilumab on Allergic Contact Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects With Allergic Contact Dermatitis n=17 Participants Dupilumab 600 mg/4 mL subcutaneously once, then 300 mg/2 mL every 2 weeks for 10 weeks Dupilumab: See arm/group description
Age, Categorical <=18 years	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=24 Participants
Age, Categorical >=65 years	8 Participants n=24 Participants
Sex: Female, Male Female	11 Participants n=24 Participants
Sex: Female, Male Male	6 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	3 Participants n=24 Participants
Race (NIH/OMB) White	13 Participants n=24 Participants
Race (NIH/OMB) More than one race	1 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants

PRIMARY outcome

Timeframe: week 0, week 6, week 12

The investigator's global assessment is a physician-reported global assessment of disease activity (range 0-4) with 0 being clear and 4 being severe.

Outcome measures

Outcome measures
Measure	Subjects With Allergic Contact Dermatitis n=6 Participants Dupilumab 600 mg/4 mL subcutaneously once, then 300 mg/2 mL every 2 weeks for 10 weeks Dupilumab: See arm/group description
Change From Baseline in Investigator's Global Assessment (IGA) Score Week 12	0.83 mean IGA scores Interval 0.4 to 1.26
Change From Baseline in Investigator's Global Assessment (IGA) Score Week 0	3.5 mean IGA scores Interval 2.93 to 4.07
Change From Baseline in Investigator's Global Assessment (IGA) Score Week 6	2 mean IGA scores Interval 0.85 to 3.15

SECONDARY outcome

Timeframe: week 0, week 6, week 12

The body surface area is a physician-reported measure of the amount of disease involvement. The patient's palm size approximates 1% of body surface area involvement.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 0, week 6, week 12

The eczema-area-and-severity-index score is a composite score of disease severity and extent of disease distribution. It was initially developed for evaluation of eczema. Disease severity (range 0-3; 0 being no disease and 3 being severe disease) is a measure of redness, thickness/induration, scratching, and lichenification. Each characterization is measured separately for body regions (head and neck, trunk, upper extremities, and lower extremities) to calculate a regional score. The total score is a sum of the four body regions (range 0-72).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 0, week 6, week 12

The numerical rating scale for itch is a patient-reported measure of itch (range 0-10) with 0 being no itch and 10 being the worst imaginable itch.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 0, week 6, week 12

The Dermatology Life Quality Index is a 10-question, patient-reported instrument to assess impact of skin diseases on patient quality of life.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 0, week 6, week 12

The Sleepy-Q is a patient-derived, patient-reported sleep questionnaire for patients with chronic inflammatory dermatoses that consists of 28 individual questions. It assesses four dimensions of sleep in patients with inflammatory skin conditions: sleep disturbance (overall score 0-40, 0 being "no sleep disturbance" and 40 being "severe sleep disturbance"), causes of sleep disturbance related to dermatitis (binary, yes/no), causes of sleep disturbance unrelated to dermatitis (binary, yes/no), and impairment related to sleep disturbance (two subscales including Life Impairment Score = overall 0-40, being 0 "no life impairment" and 40 "severe life impairment" and Dermatitis Impairment Score = overall 0-30, being 0 "no impairment" and 30 "severe impairment." The total impairment related to sleep disturbance is scored overall 0-70 after summing of the two subscales).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week0+72-120 hours and week 12+72-120 hours

Inflammatory markers (Th1, Th2, Th17, Th22 immune pathways) in the skin of patients will be evaluated before and after dupilumab.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 0, week0+72-120 hours, week 12 and week 12+72-120 hours

Inflammatory markers (Th1, Th2, Th17, Th22 immune pathways) in the blood of patients will be evaluated before and after dupilumab.

Outcome measures

Outcome data not reported

Adverse Events

Subjects With Allergic Contact Dermatitis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

BWH Dermatology Research Project Coordinator

Brigham and Women's Hospital

Phone: 617-264-5696

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place