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

Central Centrifugal Cicatricial Alopecia Clinical Trial

— CCCA  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05416320
• Other study ID #: IRB00076702
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: August 2023
• Est. completion date: December 2023

Study information

• Verified date: August 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)"

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Central Centrifugal Cicatricial Alopecia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

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