Alopecia AreataPhase 3NCT03651752
DPCP for the Treatment of Alopecia Areata
A Phase 3 study testing Diphenylcyclopropenone (DPCP) Ointment in people with Alopecia Areata, run by University of Minnesota at 1 site in United States.
Trial summary
This is an open labeled study to determine the response and characteristics, safety and efficacy, of the proprietary DPCP ointment composition as a topical immunotherapeutic agent for the treatment of extensive alopecia areata. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Diphenylcyclopropenone (DPCP) Ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 1 Sep 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has clinical diagnosis of extensive alopecia areata (76%-99% involvement as determined by SALT score, Appendix B, Part I).
- Written informed consent and HIPAA authorization have been obtained.
- Subject is > 18 to years of age.
- Female subjects of childbearing potential have a negative pregnancy test and agree to use an acceptable, highly effective method of birth control (i.e., failure rate of less than 1% per year) to prevent pregnancy.
- Subject agrees to comply with protocol requirements and attend all required study visits and is considered to be a good study subject.
- Subject meets concomitant medication washout requirements
- -
Who cannot join
- Subject has <76 or greater than 99% hair loss.
- Subject is pregnant or lactating.
- Subject has current controlled or uncontrolled bacterial, viral (with the exception of herpes simplex), fungal, atypical, or opportunistic infection(s).
- Subject has a history of substance abuse within the past five years.
- Immunosuppression (history of transplantation, chemotherapy, splenectomy, HIV).
- Administration of systemic treatment (e.g., Imuran, biologics) that have an immunomodulatory mechanism of action in the preceding 3 months.
Show all 19Show fewer
- Previous treatment with DPCP.
- Application of topical immunomodulating agent in the preceding 6 weeks.
- Application of topical or intralesional corticosteroids within the past 6 weeks.
- Systemic (oral, inhaled, or intravenous) administration of corticosteroid or other systemic treatment (i.e., prednisone) with an immunosuppressive mechanism of action within the past 3 months.
- Use of light treatments (e.g., PUVA, narrow band UVB) in the preceding 6 weeks.
- Use of Anthralin in preceding 6 weeks.
- Use of minoxidil, topical or oral, in the preceding 4 weeks.
- Subject is currently or has undergone systemic therapy for malignancy within the past five years except for adequately treated Squamous Cell Carcinoma (SCC) or Basal Cell Carcinoma (BCC) of the skin.
- Clinical evidence of secondary skin infection (i.e., folliculitis).
- Participation in other therapeutic investigational clinical trials within 4 weeks of enrollment.
- Evidence of anemia, thyroid disease, sarcoidosis or other medical condition that could be adversely affected by participating in the study.
- Subject has any medical condition that, in the judgment of the Investigator, would jeopardize the subject's safety following exposure to the administered medications.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Department of Dermatology
Minneapolis, Minnesota, 55455
About this study
Official title: An Open-Label Study to Evaluate DPCP Ointment for the Treatment of Alopecia Areata
This is an open labeled study to determine the response and characteristics, safety and efficacy, of the proprietary DPCP ointment composition as a topical immunotherapeutic agent for the treatment of extensive alopecia areata.
Read the detailed description
This is an open labeled study to determine the response and characteristics, safety and efficacy, of the proprietary DPCP ointment composition as a topical immunotherapeutic agent for the treatment of extensive alopecia areata.
Up to 10 subjects with 76% to 99% scalp hair loss that, in the opinion of the PI, are eligible for treatment with DPCP will be enrolled. Patients will be recruited from the new and current patient population seen for alopecia areata through the University of Minnesota Medical Center Dermatology Clinic as well as through partnership with the National Alopecia Areata Foundation Clinical Trials Network, and various media outlets.
The products to be evaluated are as follows:
- 0.05 mL of 0.4% DPCP (sensitization dose) applied topically to the inner aspect of the upper right arm. ("Sensitization and Baseline Sample Collection Visit")
- 0.05 mL four dose concentration matrix of DPCP ointment (0.1, 0.05, 0.01, 0.005%) prepared through dilutions in a non-volatile vehicle (applied to the inner aspect of the left upper thigh). ("Dose Determination Visit"; 10-14 days after the Sensitization Visit)If sensitization is not attained after 10 to 14 days, the procedure will be repeated once.
The subject will return 2 days after the Dose Determination Visit, so the PI or co-PI can assess the dose concentration matrix. The weakest strength concentration that caused a minimal reaction will be used throughout the study. 0.75-1 g of the treatment drug will be aThe treatment drug will be applied by the PI, a trained study coordinator, or a staff member of the Clinical Research Unit at the University of Minnesota. Eligible subjects may begin receiving the study drug immediately after enrollment and screening.
The estimated duration of the study is 22 weeks. See Appendix A for the schedule of visits. There will be a total of 42 visits, beginning with a screening visit followed by a single sensitizing dose of study drug at baseline (Day -16) and a dose determination application at Day -2.
Subjects will undergo twice weekly (+/- 2 days) topical applications of an ointment formulation of DPCP during Weeks 1-18. Application will be done twice per week. The drug application will be performed by a board certified dermatologist for the first two treatment visits (Days 0 and 3; Visits 4 and 5), after which a trained member of the Clinical Research Unit staff will apply the drug twice each week (Weeks 2-18; Visits 6-39). The investigator will attend one treatment visit in the Clinical Research Unit each month to evaluate the extent of hair loss and hair growth (Weeks 4, 8, 12, and 16).
Scalp biopsy specimen collection will be performed at baseline (Day -16, Visit 2), three days after the first treatment (i.e., challenge) application (Day 2, Visit 5), three days after the final application (Week 18 +3d, Visit 39) or during treatment when the study subject is determined to have achieved >=50% hair regrowth.
Three scalp biopsy samples will be collected by a board certified dermatologist. When possible, each sample will be taken from a balding area near an area with hair preferably in a non-androgen dependent site of the scalp. One of the three samples will be frozen in OCT for histologic examination and immunohistochemical studies. A second biopsy sample from an adjacent area will be placed in 10% buffered formalin for histologic examination and assessment of inflammation and hair follicle differentiation. The third sample from each area will immediately be placed in RNAlater (Qiagen, Valencia, CA) for cytokine expression analyses.
Peripheral blood collection for the study will include whole blood for serum and obtaining peripheral blood mononuclear cells (PBMCs). All blood samples will be transported to the Dermatology laboratory at the University of Minnesota for immediate processing and storage for additional biomarker studies.
Research coordinators will be involved in patient recruitment, contact, and scheduling. The PI and research coordinators will all be involved in the collection, analysis, and reporting of collected data.
applied in a thin film that covers the entire scalp.
- Conditions
- Alopecia Areata
- Being tested
- Diphenylcyclopropenone (DPCP) Ointment
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diphenylcyclopropenone (DPCP) OintmentDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Diphenylcyclopropenone (DPCP) Ointment | Other | 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 Receives: Drug: Diphenylcyclopropenone (DPCP) Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Alopecia Areata That Have Increased Hair Growth as Assessed by SALT Score
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)
Measured: 18 weeks
Secondary outcomes (2)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
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
Measured: 18 weeks
Determine the Best Starting Dose Range for Future Studies
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.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start1 Apr 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Why it stopped: The study was paused/enrollment on hold after 4 screen failed subjects. No further subjects were enrolled, therefore, no data was available to collect/analyze.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Alopecia Areata Foundation
- Responsible party
- Sponsor
- Investigators
- Maria Hordinsky, MD, Principal investigator, University of MN Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651752
- Sponsor's protocol ID
- DERM-2016-25380
- Status last verified
- Jan 2026
- First submitted
- 3 Aug 2018
- Last updated
- 26 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate DPCP Ointment for the Treatment of Alopecia Areata
- ClinicalTrials.gov ID
- NCT03651752
- Acronym / sponsor ID
- DERM-2016-25380
- Conditions
- Alopecia Areata
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was paused/enrollment on hold after 4 screen failed subjects. No further subjects were enrolled, therefore, no data was available to collect/analyze.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Alopecia Areata Foundation
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Posted 26 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open labeled study to determine the response and characteristics, safety and efficacy, of the proprietary DPCP ointment composition as a topical immunotherapeutic agent for the treatment of extensive alopecia areata.
Detailed description
This is an open labeled study to determine the response and characteristics, safety and efficacy, of the proprietary DPCP ointment composition as a topical immunotherapeutic agent for the treatment of extensive alopecia areata.
Up to 10 subjects with 76% to 99% scalp hair loss that, in the opinion of the PI, are eligible for treatment with DPCP will be enrolled. Patients will be recruited from the new and current patient population seen for alopecia areata through the University of Minnesota Medical Center Dermatology Clinic as well as through partnership with the National Alopecia Areata Foundation Clinical Trials Network, and various media outlets.
The products to be evaluated are as follows:
- 0.05 mL of 0.4% DPCP (sensitization dose) applied topically to the inner aspect of the upper right arm. ("Sensitization and Baseline Sample Collection Visit")
- 0.05 mL four dose concentration matrix of DPCP ointment (0.1, 0.05, 0.01, 0.005%) prepared through dilutions in a non-volatile vehicle (applied to the inner aspect of the left upper thigh). ("Dose Determination Visit"; 10-14 days after the Sensitization Visit)If sensitization is not attained after 10 to 14 days, the procedure will be repeated once.
The subject will return 2 days after the Dose Determination Visit, so the PI or co-PI can assess the dose concentration matrix. The weakest strength concentration that caused a minimal reaction will be used throughout the study. 0.75-1 g of the treatment drug will be aThe treatment drug will be applied by the PI, a trained study coordinator, or a staff member of the Clinical Research Unit at the University of Minnesota. Eligible subjects may begin receiving the study drug immediately after enrollment and screening.
The estimated duration of the study is 22 weeks. See Appendix A for the schedule of visits. There will be a total of 42 visits, beginning with a screening visit followed by a single sensitizing dose of study drug at baseline (Day -16) and a dose determination application at Day -2.
Subjects will undergo twice weekly (+/- 2 days) topical applications of an ointment formulation of DPCP during Weeks 1-18. Application will be done twice per week. The drug application will be performed by a board certified dermatologist for the first two treatment visits (Days 0 and 3; Visits 4 and 5), after which a trained member of the Clinical Research Unit staff will apply the drug twice each week (Weeks 2-18; Visits 6-39). The investigator will attend one treatment visit in the Clinical Research Unit each month to evaluate the extent of hair loss and hair growth (Weeks 4, 8, 12, and 16).
Scalp biopsy specimen collection will be performed at baseline (Day -16, Visit 2), three days after the first treatment (i.e., challenge) application (Day 2, Visit 5), three days after the final application (Week 18 +3d, Visit 39) or during treatment when the study subject is determined to have achieved >=50% hair regrowth.
Three scalp biopsy samples will be collected by a board certified dermatologist. When possible, each sample will be taken from a balding area near an area with hair preferably in a non-androgen dependent site of the scalp. One of the three samples will be frozen in OCT for histologic examination and immunohistochemical studies. A second biopsy sample from an adjacent area will be placed in 10% buffered formalin for histologic examination and assessment of inflammation and hair follicle differentiation. The third sample from each area will immediately be placed in RNAlater (Qiagen, Valencia, CA) for cytokine expression analyses.
Peripheral blood collection for the study will include whole blood for serum and obtaining peripheral blood mononuclear cells (PBMCs). All blood samples will be transported to the Dermatology laboratory at the University of Minnesota for immediate processing and storage for additional biomarker studies.
Research coordinators will be involved in patient recruitment, contact, and scheduling. The PI and research coordinators will all be involved in the collection, analysis, and reporting of collected data.
applied in a thin film that covers the entire scalp.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diphenylcyclopropenone (DPCP) Ointment | Other | Drug: Diphenylcyclopropenone (DPCP) OintmentAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject has clinical diagnosis of extensive alopecia areata (76%-99% involvement as determined by SALT score, Appendix B, Part I).
- Written informed consent and HIPAA authorization have been obtained.
- Subject is > 18 to years of age.
- Female subjects of childbearing potential have a negative pregnancy test and agree to use an acceptable, highly effective method of birth control (i.e., failure rate of less than 1% per year) to prevent pregnancy.
- Subject agrees to comply with protocol requirements and attend all required study visits and is considered to be a good study subject.
Key exclusion criteria (19 listed)
- Subject has <76 or greater than 99% hair loss.
- Subject is pregnant or lactating.
- Subject has current controlled or uncontrolled bacterial, viral (with the exception of herpes simplex), fungal, atypical, or opportunistic infection(s).
- Subject has a history of substance abuse within the past five years.
- Immunosuppression (history of transplantation, chemotherapy, splenectomy, HIV).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diphenylcyclopropenone (DPCP) OintmentAll 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 | Drug | Diphenylcyclopropenone (DPCP) Ointment |
Primary outcome
Number of Participants With Alopecia Areata That Have Increased Hair Growth as Assessed by SALT Score
Time frame: 18 weeks
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)
2 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 18 weeks
Determine the Best Starting Dose Range for Future Studies
Time frame: 18 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Hordinsky, MD principal investigator
University of MN Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diphenylcyclopropenone (DPCP) Ointment in people with Alopecia Areata, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Alopecia Areata That Have Increased Hair Growth as Assessed by SALT Score (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.