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

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

Status
Withdrawn
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05416320
Acronym
CCCA
Enrollment
0
Registered
2022-06-13
Start date
2023-08-31
Completion date
2023-12-31
Last updated
2023-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Centrifugal Cicatricial Alopecia

Keywords

hair loss, hair follicle regrowth

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)

Interventions

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

DRUGSubject'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.

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Amount of hairline stabilizationBaselineStandardized camera and dermatoscopic photographs

Secondary

MeasureTime frameDescription
Amount of hair regrowthBaseline, Month 2, Month 4, and Month 6Standardized camera and dermatoscopic photographs
Signs and symptoms of disease scoreMonth 2, Month 4, and Month 6standardized questionnaire - higher scores denotes worse condition
Dermatology Life Quality Index scoreBaseline and Month 6scores of not at all to very much

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026