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

NCT ID: NCT05416320

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2023-12-31

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)"

Conditions

Central Centrifugal Cicatricial Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Calcipotriol

Intervention Type: DRUG

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

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.

Group Type: SHAM_COMPARATOR

Subject's already prescribed drug

Intervention Type: 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.

Interventions

Calcipotriol

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

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.

Intervention Type: DRUG

Other Intervention Names

Dovonex

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy McMichael, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00076702

Identifier Type: -

Identifier Source: org_study_id