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DPCP for the Treatment of Alopecia Areata

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ClinicalTrials.gov Identifier: NCT03651752
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
National Alopecia Areata Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: Diphenylcyclopropenone (DPCP) Ointment Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Evaluate DPCP Ointment for the Treatment of Alopecia Areata
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: 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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 18 weeks ]
    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

  2. Determine the best starting dose range for future studies [ Time Frame: 18 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has clinical diagnosis of extensive alopecia areata (76%-99% involvement as determined by SALT score, Appendix B, Part I).
  2. Written informed consent and HIPAA authorization have been obtained.
  3. Subject is > 18 to years of age.
  4. 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.
  5. Subject agrees to comply with protocol requirements and attend all required study visits and is considered to be a good study subject.
  6. Subject meets concomitant medication washout requirements

    -

Exclusion Criteria:

  1. Subject has <76 or greater than 99% hair loss.
  2. Subject is pregnant or lactating.
  3. Subject has current controlled or uncontrolled bacterial, viral (with the exception of herpes simplex), fungal, atypical, or opportunistic infection(s).
  4. Subject has a history of substance abuse within the past five years.
  5. Immunosuppression (history of transplantation, chemotherapy, splenectomy, HIV).
  6. Administration of systemic treatment (e.g., Imuran, biologics) that have an immunomodulatory mechanism of action in the preceding 3 months.
  7. Previous treatment with DPCP.
  8. Application of topical immunomodulating agent in the preceding 6 weeks.
  9. Application of topical or intralesional corticosteroids within the past 6 weeks.
  10. 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.
  11. Use of light treatments (e.g., PUVA, narrow band UVB) in the preceding 6 weeks.
  12. Use of Anthralin in preceding 6 weeks.
  13. Use of minoxidil, topical or oral, in the preceding 4 weeks.
  14. 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.
  15. Clinical evidence of secondary skin infection (i.e., folliculitis).
  16. Participation in other therapeutic investigational clinical trials within 4 weeks of enrollment.
  17. Evidence of anemia, thyroid disease, sarcoidosis or other medical condition that could be adversely affected by participating in the study.
  18. Subject has any medical condition that, in the judgment of the Investigator, would jeopardize the subject's safety following exposure to the administered medications.

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651752


Contacts
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Contact: Irmina o Wallander, BA 6126245721 wall0396@umn.edu
Contact: Dayna Cohen, MS 6126245721 cohen374@umn.edu

Locations
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United States, Minnesota
University of Minnesota Department of Dermatology Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Irmina o Wallander, BA    612-624-5721    wall0396@umn.edu   
Contact: Dayna o Cohen, MS    6126245721    cohen374@umn.edu   
Principal Investigator: Maria Hordinsky, MD         
University of Minnesota Department of Dermatology Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Irmina Wallander, BA    612-624-5721    wall0396@umn.edu   
Contact: Dayna Cohen, MS    612-624-5721    cohen374@umn.edu   
Principal Investigator: Maria Hordinsky, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Alopecia Areata Foundation
Investigators
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Principal Investigator: Maria o Hordinsky, MD University of MN Department of Dermatology

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03651752     History of Changes
Other Study ID Numbers: 1407M52002
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical