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| Name | Class |
|---|---|
| The Skin of Color Society | UNKNOWN |
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The objective of this study is to examine photos of CCCA patients taken before and after treatment to compare treatment outcomes between different treatment groups
Treatment groups that patients will be randomized to include 1) topical steroid plus oral antibiotic group, and topical minoxidil after 8 months 2) topical steroid plus intralesional steroid group and topical minoxidil after 8 months. Both these regimens are used as the first-line treatments by clinicians. The objective of this study is to examine photos of CCCA patients taken before and after treatment to compare treatment outcomes between different treatment groups.
In this study, the investigators are looking to determine how standard treatment affects the outcome of central centrifugal cicatricial alopecia; to determine if topical steroid with With Doxycycline has better outcome than topical steroids with intralesional steroids in central centrifugal cicatricial alopecia, and to determine how the addition of topical minoxidil as a treatment changes the outcome of central centrifugal cicatricial alopecia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical steroid plus oral antibiotic group | Active Comparator | Participants in this group receive topical steroid (class I-II applied once daily) plus oral antibiotic group (doxycyline 100 mg twice daily for 6 months), and then topical minoxidil (5% solution or foam) after 8 months of treatment. |
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| Topical steroid plus intralesional steroid injection group | Active Comparator | Participants in this group receive topical steroid (class I-II applied once daily) plus intralesional steroid group (7.5mg/cc of kenaolog, max dose of 3 cc), and then topical minoxidil (5% solution or foam) after 8 months of treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical steroid class I-II | Drug | applied once daily - 18 month duration of the study |
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| Measure | Description | Time Frame |
|---|---|---|
| Central Scalp Alopecia Photographic Scale in African American Women | Photographs of the subject's scalp will be taken at baseline. This instrument is a 6-point scale that includes gradations in hair loss from normal (0) to bald scalp (5). Higher numbers denote greater hair loss. | baseline |
| Central Scalp Alopecia Photographic Scale in African American Women | This instrument is a 6-point scale that includes gradations in hair loss from normal (0) to bald scalp (5). Higher numbers denote greater hair loss. | Visit 4, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Hair Loss Questionnaire | Questionnaire gathers the epidemiologic data about the patient's hair loss, family history of hair loss, what treatments have been tried in the past, and hair care practices. There is no range and/or direction as this questionnaire is used to gather descriptive data. | Baseline, Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20 |
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Inclusion Criteria:
Exclusion Criteria:
African-American women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy J McMichael, MD | Contact | 336.716.3926 | amcmichael@wakehealth.edu | |
| Judy Holbrook, CRC | Contact | 336.716.8991 | jholbroo@wakehealth.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amy J McMichael, MD | Wake Forest Baptist Health Department of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health Department of Dermatology | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1739290 | Background | Sperling LC, Sau P. The follicular degeneration syndrome in black patients. 'Hot comb alopecia' revisited and revised. Arch Dermatol. 1992 Jan;128(1):68-74. | |
| 22092575 | Background | Bin Saif GA, Ericson ME, Yosipovitch G. The itchy scalp--scratching for an explanation. Exp Dermatol. 2011 Dec;20(12):959-68. doi: 10.1111/j.1600-0625.2011.01389.x. |
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Treatment groups that patients will be randomized to include 1) topical steroid plus oral antibiotic group, and topical minoxidil after 8 months 2) topical steroid plus intralesional steroid group and topical minoxidil after 8 months.
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To help ensure subject privacy and confidentiality, only a unique study identifier will appear on the data collection form. The data collected will be stored on the Research Electronic Database CaptureTM with access limited to designated study personnel.
Blinded investigators from Wake Forest Baptist Department of Dermatology will later review photographs of each subject taken at baseline and at month 18 and will assign severity scores to the photographs based on the Central Scalp Alopecia Scale. These investigators will not know when each photograph was taken.
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| Triamcinolone Acetonide | Drug | Intralesional Steroid Injection, 7.5mg/cc. max dose of 3 cc. Scalp injections will be administered every 6-8 weeks, for a total of 8 injections. |
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| Doxycyline | Drug | oral antibiotic twice daily for 6 months |
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| Minoxidil | Drug | 5% solution or foam started after month 8 |
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| Dermatology Life Quality Index (DLQI) | Questionnaire measures how CCCA and the symptoms associated have affected daily activities over the past week. A 5-point scale is used. It ranges from 'Very Much' to 'Not Relevant' with 'Very Much' meaning that it negatively affects their daily living and quality of life and 'Not Relevant' meaning that it has no effect on their daily living and quality of life. | Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20 |
| Last Year Dermatology Life Quality Index (LYDLQI) | Questionnaire measures how CCCA and the symptoms associated have affected daily activities over the past year. A 5-point scale is used. It ranges from 'Very Much' to 'Not Relevant' with 'Very Much' meaning that it negatively affects their daily living and quality of life and 'Not Relevant' meaning that it has no effect on their daily living and quality of life. | Baseline |
| Central Scalp Alopecia Photographic Scale in African American Women | This instrument is a 6-point scale that includes gradations in hair loss from normal (0) to bald scalp (5). Higher numbers denote greater hair loss. | Visit 7, Month 12; Visit 9, Month 18-20 |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002990 | Clobetasol |
| C011175 | betamethasone-17,21-dipropionate |
| D005447 | Fluocinonide |
| D014222 | Triamcinolone Acetonide |
| D004318 | Doxycycline |
| D008914 | Minoxidil |
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D013259 | Steroids, Fluorinated |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D005446 | Fluocinolone Acetonide |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D014221 | Triamcinolone |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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