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Calcipotriol as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA)

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05416320
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
10
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this pilot study is to determine if calcipotriol shows potential to be an effective treatment for Central Centrifugal Cicatricial Alopecia (CCCA). This study aims to evaluate calcipotriol due to the possible anti-inflammatory effects that may affect the hair growth cycle.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Detailed Description

Calcipotriol, a vitamin D analog, has been topically used to treat alopecia areata, a form of non-scarring autoimmune alopecia in several studies. It is possible that Vitamin D plays a role in sustaining the hair follicle's immune privilege through anti-inflammatory effects such as controlling Interferon gamma (IFN-γ) production. A recent study showed a significant decrease of vitamin D in Black patients with Central Centrifugal Cicatricial Alopecia (CCCA)"

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
10 patients for the study will be randomized to one of two groups who consent to participate in a novel treatment with calcipotriol, or the control (no additional treatment besides Subject's already prescribed drug)10 patients for the study will be randomized to one of two groups who consent to participate in a novel treatment with calcipotriol, or the control (no additional treatment besides Subject's already prescribed drug)
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study of Calcipotriol as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Calcipotriol Group

Subjects will use the topical formulation once daily on the scalp. The subjects will use the treatment for a total of 6 months.

Drug: Calcipotriol
Subjects will use the topical formulation once daily on the scalp. The subjects will use the treatment for a total of 6 months.
Other Names:
  • Dovonex

    		•
    Sham Comparator: Control Group

    Subjects will continue to use their primary physician prescribed topical formulation once daily on the scalp. The subjects will use their treatment for a total of 6 months.

    Drug: Subject's already prescribed drug
    Subjects will continue to use their already prescribed topical formulation once daily on the scalp. The subjects will use their treatment for a total of 6 months.

    Outcome Measures

    Primary Outcome Measures

    1. Amount of hairline stabilization [Baseline]

      Standardized camera and dermatoscopic photographs

    2. Amount of hairline stabilization [Month 2]

      Standardized camera and dermatoscopic photographs

    3. Amount of hairline stabilization [Month 4]

      Standardized camera and dermatoscopic photographs

    4. Amount of hairline stabilization [Month 6]

      Standardized camera and dermatoscopic photographs

    Secondary Outcome Measures

    1. Amount of hair regrowth [Baseline, Month 2, Month 4, and Month 6]

      Standardized camera and dermatoscopic photographs

    2. Signs and symptoms of disease score [Month 2, Month 4, and Month 6]

      standardized questionnaire - higher scores denotes worse condition

    3. Dermatology Life Quality Index score [Baseline and Month 6]

      scores of "not at all" to "very much"

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Women who are eighteen years of age or older

    • biopsy-proven and/or clinical diagnosis of CCCA Stage II-IV

    • must be on stable treatment without changes for at least 3 months

    • Subjects will be recruited from outpatient dermatology clinics at the Wake Forest Baptist Health Department of Dermatology.

    Exclusion Criteria:
    • Males

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157

    Sponsors and Collaborators

    • Wake Forest University Health Sciences

    Investigators

    • Principal Investigator: Amy McMichael, MD, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT05416320
    Other Study ID Numbers:
    • IRB00076702
    First Posted:
    Jun 13, 2022
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Wake Forest University Health Sciences
    hair loss
    hair follicle regrowth
    Additional relevant MeSH terms:
    Alopecia
    Alopecia Areata
    Calcipotriene

    Study Results

    No Results Posted as of Jul 27, 2022