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

NCT05416320 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: IRB00076702
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Centrifugal Cicatricial Alopecia

Keywords

hair loss; hair follicle regrowth

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Amount of hair regrowth

  Baseline, Month 2, Month 4, and Month 6

• Signs and symptoms of disease score

  Month 2, Month 4, and Month 6

• Dermatology Life Quality Index score

  Baseline and Month 6

Study Arms (2)

Calcipotriol Group

EXPERIMENTAL

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

Control Group

SHAM COMPARATOR

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

Interventions

Calcipotriol DRUG

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

Also known as: Dovonex

Calcipotriol Group

Subject's already prescribed drug 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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Males

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Alopecia

Interventions

calcipotriene

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Amy McMichael, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 13, 2022
• Study Start: August 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)