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

A Pilot Study of Calcipotriol as a Novel Treatment for Central Centrifugal Cicatricial Alopecia

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.

Study Overview

• Status: Withdrawn
• Conditions: Central Centrifugal Cicatricial Alopecia
• Intervention / Treatment: Drug: Calcipotriol; Drug: Subject's already prescribed drug

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 Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jorge F Larrondo, MD; Phone Number: (336)716-3926; Email: jflarron@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
      • Contact: Jorge F Lorrando, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of hairline stabilization	Standardized camera and dermatoscopic photographs	Baseline
Amount of hairline stabilization	Standardized camera and dermatoscopic photographs	Month 2
Amount of hairline stabilization	Standardized camera and dermatoscopic photographs	Month 4
Amount of hairline stabilization	Standardized camera and dermatoscopic photographs	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of hair regrowth	Standardized camera and dermatoscopic photographs	Baseline, Month 2, Month 4, and Month 6
Signs and symptoms of disease score	standardized questionnaire - higher scores denotes worse condition	Month 2, Month 4, and Month 6
Dermatology Life Quality Index score	scores of "not at all" to "very much"	Baseline and Month 6

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: hair loss; hair follicle regrowth
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Dermatologic Agents; Calcipotriene
• Other Study ID Numbers: IRB00076702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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