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The IRB was closed without enrolling any participants
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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.
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)"
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of hair regrowth | Standardized camera and dermatoscopic photographs | Baseline, Month 2, Month 4, and Month 6 |
| Signs and symptoms of disease score | standardized questionnaire - higher scores denotes worse condition |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Amy McMichael, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C055085 | calcipotriene |
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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)
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| 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. |
|
| Month 2, Month 4, and Month 6 |
| Dermatology Life Quality Index score | scores of "not at all" to "very much" | Baseline and Month 6 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |