Clinical trial NCT03651752: DPCP for the Treatment of Alopecia Areata
Official title: An Open-Label Study to Evaluate DPCP Ointment for the Treatment of Alopecia Areata
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alopecia Areata
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Alopecia Areata Foundation
First posted: 2018-08-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

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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.

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Primary outcomes:
measure: Number of participants with Alopecia Areata that have increased hair growth as assessed by SALT score
timeFrame: 18 weeks
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 18 weeks
measure: Determine the best starting dose range for future studies
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Department of Dermatology
state: Minnesota
Study officials:
affiliation: University of MN Department of Dermatology
name: Maria Hordinsky, MD
role: PRINCIPAL_INVESTIGATOR
References: