Central Centrifugal Cicatricial AlopeciaEarly Phase 1CCCANCT05416320
Calcipotriol as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA)
A Early Phase 1 study testing Calcipotriol and Subject's already prescribed drug in people with Central Centrifugal Cicatricial Alopecia, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Central Centrifugal Cicatricial Alopecia
- What is being tested?
- Calcipotriol and Subject's already prescribed drug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2023to Dec 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Males
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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
- Being tested
- Calcipotriol, Subject's already prescribed drug
- Keywords
- hair loss, hair follicle regrowth
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcipotriolDrug
Also called Dovonex
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 drugDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Subject's already prescribed drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of hairline stabilization
Standardized camera and dermatoscopic photographs
Measured: Baseline
Amount of hairline stabilization
Standardized camera and dermatoscopic photographs
Measured: Month 2
Amount of hairline stabilization
Standardized camera and dermatoscopic photographs
Measured: Month 4
Amount of hairline stabilization
Standardized camera and dermatoscopic photographs
Measured: Month 6
Secondary outcomes (3)
Amount of hair regrowth
Standardized camera and dermatoscopic photographs
Measured: Baseline, Month 2, Month 4, and Month 6
Signs and symptoms of disease score
standardized questionnaire - higher scores denotes worse condition
Measured: Month 2, Month 4, and Month 6
Dermatology Life Quality Index score
scores of "not at all" to "very much"
Measured: Baseline and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study startAug 2023 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: The IRB was closed without enrolling any participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Centrifugal Cicatricial AlopeciaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy McMichael, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416320
- Sponsor's protocol ID
- IRB00076702
- Acronym
- CCCA
- Status last verified
- Aug 2023
- First submitted
- 8 Jun 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Calcipotriol as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
- ClinicalTrials.gov ID
- NCT05416320
- Acronym / sponsor ID
- CCCA / IRB00076702
- Conditions
- Central Centrifugal Cicatricial Alopecia
- Keywords
- hair loss, hair follicle regrowth
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The IRB was closed without enrolling any participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Calcipotriol Group | Experimental | Drug: CalcipotriolSubjects will use the topical formulation once daily on the scalp. The subjects will use the treatment for a total of 6 months. |
| Control Group | Sham comparator | Drug: Subject's already prescribed drugSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Males
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CalcipotriolAlso: DovonexSubjects will use the topical formulation once daily on the scalp. The subjects will use the treatment for a total of 6 months. | Drug | Calcipotriol Group |
| Subject's already prescribed drugSubjects 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. | Drug | Control Group |
Primary outcome
Amount of hairline stabilization
Time frame: Baseline
Standardized camera and dermatoscopic photographs
Amount of hairline stabilization
Time frame: Month 2
Standardized camera and dermatoscopic photographs
Amount of hairline stabilization
Time frame: Month 4
Standardized camera and dermatoscopic photographs
Amount of hairline stabilization
Time frame: Month 6
Standardized camera and dermatoscopic photographs
3 secondary outcomes
Amount of hair regrowth
Time frame: Baseline, Month 2, Month 4, and Month 6
Signs and symptoms of disease score
Time frame: Month 2, Month 4, and Month 6
Dermatology Life Quality Index score
Time frame: Baseline and Month 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy McMichael, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Calcipotriol and Subject's already prescribed drug in people with Central Centrifugal Cicatricial Alopecia, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of hairline stabilization (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.