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Immunotherapy
DPCP Ointment for Alopecia Areata
Phase 3
Recruiting
Led By Maria Hordinsky, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has clinical diagnosis of extensive alopecia areata (76%-99% involvement as determined by SALT score, Appendix B, Part I)
Subject is > 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 weeks
Awards & highlights
Study Summary
This trial will test a new ointment for treating hair loss due to alopecia areata. The ointment is applied topically, and the trial will measure the safety and effectiveness of the treatment.
Who is the study for?
Adults over 18 with extensive alopecia areata (76%-99% hair loss) can join this trial if they haven't used certain treatments recently, like DPCP, light therapies, or corticosteroids. They must not be pregnant or have conditions that could worsen by participating and agree to use effective birth control.Check my eligibility
What is being tested?
The study is testing a topical ointment called Diphenylcyclopropenone (DPCP) for treating extensive alopecia areata. It's an open-label trial, meaning everyone knows they're getting the actual medication to assess its safety and effectiveness.See study design
What are the potential side effects?
Possible side effects of DPCP ointment may include skin reactions at the application site such as redness, itching or swelling. Since it's an immunotherapy treatment, there might also be changes in immune response.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have extensive hair loss covering 76% to 99% of my scalp.
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I am older than 18 years.
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I am not pregnant and agree to use highly effective birth control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with Alopecia Areata that have increased hair growth as assessed by SALT score
Secondary outcome measures
Determine the best starting dose range for future studies
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diphenylcyclopropenone (DPCP) OintmentExperimental Treatment1 Intervention
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
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,379 Previous Clinical Trials
1,588,513 Total Patients Enrolled
10 Trials studying Alopecia Areata
217 Patients Enrolled for Alopecia Areata
National Alopecia Areata FoundationOTHER
5 Previous Clinical Trials
3,203 Total Patients Enrolled
5 Trials studying Alopecia Areata
3,203 Patients Enrolled for Alopecia Areata
Maria Hordinsky, MDPrincipal InvestigatorUniversity of MN Department of Dermatology
16 Previous Clinical Trials
448 Total Patients Enrolled
8 Trials studying Alopecia Areata
199 Patients Enrolled for Alopecia Areata
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any immune system-modifying drugs in the last 3 months.I have not used minoxidil in the last 4 weeks.I have or am receiving cancer treatment, except for skin cancer, in the last 5 years.I have not used light treatments like PUVA or UVB in the last 6 weeks.I have extensive hair loss covering 76% to 99% of my scalp.I have a condition like anemia or thyroid disease that could worsen by joining this study.I have been treated with DPCP before.I have not used Anthralin in the last 6 weeks.I am older than 18 years.I am not pregnant and agree to use highly effective birth control.I do not have any serious infections, except for herpes simplex.I have a weakened immune system due to a transplant, chemotherapy, spleen removal, or HIV.I haven't used any skin creams or injections for my condition in the last 6 weeks.I have used a skin cream for immune system modulation in the last 6 weeks.You have had a problem with drugs or alcohol in the last five years.I have a skin infection related to hair follicles.I have lost less than 76% or more than 99% of my hair.I haven't taken any steroids or immunosuppressants in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Diphenylcyclopropenone (DPCP) Ointment
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the risks associated with this care option?
"There is some evidence for the efficacy of this treatment from Phase 3 trials, as well as multiple rounds of data supporting safety, which gives it a score of 3 on our team's estimation."
Answered by AI
How many people are being recruited for this clinical trial?
"The listing on clinicaltrials.gov says that the investigators are still looking for participants. This trial was first advertised on November 1st, 2019 and has been updated as recently as May 4th, 2022. They need 10 more patients at a single location."
Answered by AI
Are people with the specified medical condition able to participate in this trial at this time?
"The listing for this clinical trial on clinicaltrials.gov shows that the study is actively recruiting patients. The first posting was on November 1st, 2019 and there have been edits as recently as May 4th, 2022."
Answered by AI
Can you provide some contextual information about this proposed treatment?
"There are presently 2 concurrent clinical trials studying this intervention, 1 of which is in Phase 3. Most of the research for this treatment occurs in Minneapolis, Minnesota; however, there are 2 sites running these studies."
Answered by AI
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