Trial Outcomes & Findings for DPCP for the Treatment of Alopecia Areata (NCT NCT03651752)

NCT ID: NCT03651752

Last Updated: 2026-01-26

Results Overview

Efficacy will be assessed as follows; a. Severity of Alopecia tool (SALT) score: Percentage of hair loss on the scalp will be determined using he SALT score, a global alopecia areata severity score based on scalp hair loss. The SALT score is calculated by visually examining four descrete areas of the scalp, measuring the percentage of terminal hair loss in each area. b. Scalp Photograhpy. c. Hair pull tests (positive or negative)

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 4 participants
• Primary outcome timeframe: 18 weeks
• Results posted on: 2026-01-26

Participant Flow

Participant milestones

Measure	Diphenylcyclopropenone (DPCP) Ointment All subjects will be administered a sensitization dose of 0.05 mL 0.4% DPCP ointment formulation topically in the inner aspect of the upper right arm at Day -16, and 0.05 mL of four concentrations (0.1, .05, 0.01, 0.005%), prepared through dilutions in the ointment vehicle, topically on the inner aspect of the left thigh at Day -2. The weakest strength that may cause a minimal reaction (DTH skin reaction score of 1+) after two days will be chosen, and 0.75-1 g of that concentration will be applied to the scalp starting at Week 1 and administered subsequently twice a week for 18 weeks Diphenylcyclopropenone (DPCP) Ointment: All subjects will be administered a sensitization dose of 0.05 mL 0.4% DPCP ointment formulation topically in the inner aspect of the upper right arm at Day -16, and 0.05 mL of four concentrations (0.1, .05, 0.01, 0.005%), prepared through dilutions in the ointment vehicle, topically on the inner aspect of the left thigh at Day -2. The weakest strength that may cause a minimal reaction (DTH skin reaction score of 1+) after two days will be chosen, and 0.75-1 g of that concentration will be applied to the scalp starting at Week 1 and administered subsequently twice a week for 18 weeks
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Diphenylcyclopropenone (DPCP) Ointment All subjects will be administered a sensitization dose of 0.05 mL 0.4% DPCP ointment formulation topically in the inner aspect of the upper right arm at Day -16, and 0.05 mL of four concentrations (0.1, .05, 0.01, 0.005%), prepared through dilutions in the ointment vehicle, topically on the inner aspect of the left thigh at Day -2. The weakest strength that may cause a minimal reaction (DTH skin reaction score of 1+) after two days will be chosen, and 0.75-1 g of that concentration will be applied to the scalp starting at Week 1 and administered subsequently twice a week for 18 weeks Diphenylcyclopropenone (DPCP) Ointment: All subjects will be administered a sensitization dose of 0.05 mL 0.4% DPCP ointment formulation topically in the inner aspect of the upper right arm at Day -16, and 0.05 mL of four concentrations (0.1, .05, 0.01, 0.005%), prepared through dilutions in the ointment vehicle, topically on the inner aspect of the left thigh at Day -2. The weakest strength that may cause a minimal reaction (DTH skin reaction score of 1+) after two days will be chosen, and 0.75-1 g of that concentration will be applied to the scalp starting at Week 1 and administered subsequently twice a week for 18 weeks
Overall Study Adverse Event	1
Overall Study Screen failure	3

Baseline Characteristics

DPCP for the Treatment of Alopecia Areata

Baseline characteristics by cohort

Measure	Diphenylcyclopropenone (DPCP) Ointment n=4 Participants All subjects will be administered a sensitization dose of 0.05 mL 0.4% DPCP ointment formulation topically in the inner aspect of the upper right arm at Day -16, and 0.05 mL of four concentrations (0.1, .05, 0.01, 0.005%), prepared through dilutions in the ointment vehicle, topically on the inner aspect of the left thigh at Day -2. The weakest strength that may cause a minimal reaction (DTH skin reaction score of 1+) after two days will be chosen, and 0.75-1 g of that concentration will be applied to the scalp starting at Week 1 and administered subsequently twice a week for 18 weeks Diphenylcyclopropenone (DPCP) Ointment: All subjects will be administered a sensitization dose of 0.05 mL 0.4% DPCP ointment formulation topically in the inner aspect of the upper right arm at Day -16, and 0.05 mL of four concentrations (0.1, .05, 0.01, 0.005%), prepared through dilutions in the ointment vehicle, topically on the inner aspect of the left thigh at Day -2. The weakest strength that may cause a minimal reaction (DTH skin reaction score of 1+) after two days will be chosen, and 0.75-1 g of that concentration will be applied to the scalp starting at Week 1 and administered subsequently twice a week for 18 weeks
Race (NIH/OMB) White	3 Participants n=25 Participants
Age, Categorical <=18 years	0 Participants n=25 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=25 Participants
Age, Categorical >=65 years	1 Participants n=25 Participants
Sex: Female, Male Female	4 Participants n=25 Participants
Sex: Female, Male Male	0 Participants n=25 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants
Race (NIH/OMB) Asian	1 Participants n=25 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants
Race (NIH/OMB) Black or African American	0 Participants n=25 Participants
Race (NIH/OMB) More than one race	0 Participants n=25 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants

PRIMARY outcome

Timeframe: 18 weeks

Population: The study was paused/enrollment on hold after 4 screen failed subjects, including 1 AE. No further subjects were enrolled, therefore, no data was available to collect/analyze for each outcome.

Efficacy will be assessed as follows; a. Severity of Alopecia tool (SALT) score: Percentage of hair loss on the scalp will be determined using he SALT score, a global alopecia areata severity score based on scalp hair loss. The SALT score is calculated by visually examining four descrete areas of the scalp, measuring the percentage of terminal hair loss in each area. b. Scalp Photograhpy. c. Hair pull tests (positive or negative)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 weeks

Population: The study was paused/enrollment on hold after 4 screen failed subjects, including 1 AE. No further subjects were enrolled, therefore, no data was available to collect/analyze for each outcome.

Safety will be monitored for side effects at each visit. Adverse events will be tracked for each subject from the time of the first sensitization dose application of the drug until the subject completes the study. Adverse events will be assessed for severity by the investigator and graded on a four point scale: mild, moderate, severe, or life-threatening

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 weeks

Population: The study was paused/enrollment on hold after 4 screen failed subjects, including 1 AE. No further subjects were enrolled, therefore, no data was available to collect/analyze for each outcome.

Dose determination will be assessed utilizing the Immuno Therapeutic Response Skin Reaction Scale (0-4+) with each dose dilution (.1%-.005%) placed every 72 hours on a different skin region. Biopsies will be obtained to identify scalp skin biomarker profiles that characterize a response to DPCP treatment, enabling future potential for predicting individual responses to treatment and the likelihood of a sustained response.

Outcome measures

Outcome data not reported

Adverse Events

Diphenylcyclopropenone (DPCP) Ointment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Diphenylcyclopropenone (DPCP) Ointment n=4 participants at risk All subjects will be administered a sensitization dose of 0.05 mL 0.4% DPCP ointment formulation topically in the inner aspect of the upper right arm at Day -16, and 0.05 mL of four concentrations (0.1, .05, 0.01, 0.005%), prepared through dilutions in the ointment vehicle, topically on the inner aspect of the left thigh at Day -2. The weakest strength that may cause a minimal reaction (DTH skin reaction score of 1+) after two days will be chosen, and 0.75-1 g of that concentration will be applied to the scalp starting at Week 1 and administered subsequently twice a week for 18 weeks Diphenylcyclopropenone (DPCP) Ointment: All subjects will be administered a sensitization dose of 0.05 mL 0.4% DPCP ointment formulation topically in the inner aspect of the upper right arm at Day -16, and 0.05 mL of four concentrations (0.1, .05, 0.01, 0.005%), prepared through dilutions in the ointment vehicle, topically on the inner aspect of the left thigh at Day -2. The weakest strength that may cause a minimal reaction (DTH skin reaction score of 1+) after two days will be chosen, and 0.75-1 g of that concentration will be applied to the scalp starting at Week 1 and administered subsequently twice a week for 18 weeks

Skin and subcutaneous tissue disorders Inflammatory Reaction

25.0% 1/4 • Number of events 1 • 4 weeks

Additional Information

Maria Hordinsky, MD

University of Minnesota

Phone: 612-625-9427

Email: hordi001@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place