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

Primary Purpose

Central Centrifugal Cicatricial Alopecia

Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Calcipotriol
Subject's already prescribed drug
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Centrifugal Cicatricial Alopecia focused on measuring hair loss, hair follicle regrowth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Calcipotriol Group

Control Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Amount of hairline stabilization
Standardized camera and dermatoscopic photographs
Amount of hairline stabilization
Standardized camera and dermatoscopic photographs
Amount of hairline stabilization
Standardized camera and dermatoscopic photographs
Amount of hairline stabilization
Standardized camera and dermatoscopic photographs

Secondary Outcome Measures

Amount of hair regrowth
Standardized camera and dermatoscopic photographs
Signs and symptoms of disease score
standardized questionnaire - higher scores denotes worse condition
Dermatology Life Quality Index score
scores of "not at all" to "very much"

Full Information

First Posted
June 8, 2022
Last Updated
August 28, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05416320
Brief Title
Calcipotriol as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA)
Acronym
CCCA
Official Title
A Pilot Study of Calcipotriol as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Why Stopped
The IRB was closed without enrolling any participants
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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)"

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Centrifugal Cicatricial Alopecia
Keywords
hair loss, hair follicle regrowth

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calcipotriol Group
Arm Type
Experimental
Arm Description
Subjects will use the topical formulation once daily on the scalp. The subjects will use the treatment for a total of 6 months.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Calcipotriol
Other Intervention Name(s)
Dovonex
Intervention Description
Subjects will use the topical formulation once daily on the scalp. The subjects will use the treatment for a total of 6 months.
Intervention Type
Drug
Intervention Name(s)
Subject's already prescribed drug
Intervention Description
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.
Primary Outcome Measure Information:
Title
Amount of hairline stabilization
Description
Standardized camera and dermatoscopic photographs
Time Frame
Baseline
Title
Amount of hairline stabilization
Description
Standardized camera and dermatoscopic photographs
Time Frame
Month 2
Title
Amount of hairline stabilization
Description
Standardized camera and dermatoscopic photographs
Time Frame
Month 4
Title
Amount of hairline stabilization
Description
Standardized camera and dermatoscopic photographs
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Amount of hair regrowth
Description
Standardized camera and dermatoscopic photographs
Time Frame
Baseline, Month 2, Month 4, and Month 6
Title
Signs and symptoms of disease score
Description
standardized questionnaire - higher scores denotes worse condition
Time Frame
Month 2, Month 4, and Month 6
Title
Dermatology Life Quality Index score
Description
scores of "not at all" to "very much"
Time Frame
Baseline and Month 6

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Males are excluded from this study since the prevalence of CCCA in males is so significantly low that it is difficult to find cases in a clinical setting
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy McMichael, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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