Central Centrifugal Cicatricial Alopecia
Conditions
Keywords
hair loss, scalp symptoms
Brief summary
The purpose of this study is to determine if the Revian Red All LED cap shows potential to be an effective treatment for Central centrifugal cicatricial alopecia (CCCA) by recruiting hair follicles back to anagen growth or by improving inflammation. The primary outcome is to determine if hair loss regression is halted. Secondary outcomes include hair regrowth and alleviation of signs and symptoms of the disease. Participants will be asked to use the Revian Red All LED cap once daily for a 10-minute treatment regimen which is the current androgenetic alopecia recommendation.
Detailed description
Subjects who are willing to participate in a novel treatment for Revian Red All LED cap will be enrolled in this study. The cap uses two wavelengths of light, 620 nm and 660 nm. A study cap will be provided for each subject. Subjects will use the cap once daily, 10-minute treatment regimen which is the current androgenetic alopecia recommendation. The subjects will use the cap for a total of 6 months. To use the cap, subjects will connect the Revian Red All LED cap to a Smart App on a mobile phone device using Bluetooth. Subjects can use the Smart App to set daily reminders to use the cap, track and log usage, and use the 10 minute timer. No additional information will be stored on the Smart App. Only subjects will have access to the Smart App located on their personal mobile phone device. Standardized photos and trichoscopic photos before starting treatment and every 2 months for x 6 total months will be taken to assess hairline stabilization and potential for regrowth. A baseline photo and completion photo will also be taken with a visio device. This will help determine pigmentation of the present hairs throughout the study. Prior to study enrollment, all participants will receive a detailed explanation of the purpose of the study and will undergo written informed consent. Clinical history of hair loss and history of prior treatment will be obtained by administering a standardized questionnaire to all subjects. Subjects will also fill out a questionnaire regarding symptoms of their hair loss at each visit. There will be 4 visits total (1 Pre-treatment visit and 3 Follow up visits).
Interventions
DEVICERevian Red All LED cap
The cap is a dual-band LED light therapy wireless smart cap. It has been shown to be effective in androgenetic alopecia (used once daily, 10-minute treatment regimen) for both men and women.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Women who are between the age of eighteen years and sixty-five years * Biopsy-proven diagnosis of CCCA Stage II-IV. * Must be on stable treatment without changes (on doxycycline, topical steroids, minoxidil and/or post 8 rounds of intralesional steroids) for at least 3 months
Exclusion criteria
* Subjects with other forms of hair loss that is not CCCA * Prior treatment with light source for alopecia * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shape of the Hairline Documented With Photographs | Baseline to month 6 | Photographs of the stabilization and regrowth of the hairline documented by standardized camera and dermatoscopic photographs of the scalp |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hairline Assessment Scores by Participant | Baseline to month 6 | Subjects will complete the standardized questionnaire regarding symptoms of their hair loss: Perception Dermatology Life Quality Index (DLQI) survey - The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30. |
| Change in Perifollicular Scale Assessments of Hairline Change by Study Physician | Baseline to month 6 | Scalp and hair exam and assessment with completion of grader survey to measure: Perifollicular scale Mild - affecting \<10% of scalp. Moderate - affecting 10-30% of scalp. Severe - affecting \>30% of scalp. For all signs other than Vellus/Intermediate/Terminal hair shafts: Percentage of types of hair shafts |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Using the Revian Red All LED cap 10 minutes each day for 6 months
Revian Red All LED cap: The cap is a dual-band LED light therapy wireless smart cap. It has been shown to be effective in androgenetic alopecia (used once daily, 10-minute treatment regimen) for both men and women. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 56.79 years STANDARD_DEVIATION 10.87 |
| Disease Duration | 11.75 years STANDARD_DEVIATION 8.27 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 24 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Shape of the Hairline Documented With Photographs
Photographs of the stabilization and regrowth of the hairline documented by standardized camera and dermatoscopic photographs of the scalp
Time frame: Baseline to month 6
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Shape of the Hairline Documented With Photographs | stabilization of hair loss | 8 Participants |
| Intervention | Shape of the Hairline Documented With Photographs | improvement in hair growth | 12 Participants |
| Intervention | Shape of the Hairline Documented With Photographs | worsened hair loss | 2 Participants |
Secondary
Change in Hairline Assessment Scores by Participant
Subjects will complete the standardized questionnaire regarding symptoms of their hair loss: Perception Dermatology Life Quality Index (DLQI) survey - The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.
Time frame: Baseline to month 6
Population: Secondary outcome (Alleviation of signs and symptoms of disease):
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Change in Hairline Assessment Scores by Participant | Improvement in symptoms: | 11 Participants |
| Intervention | Change in Hairline Assessment Scores by Participant | Worsened symptoms | 6 Participants |
| Intervention | Change in Hairline Assessment Scores by Participant | • Stable symptoms | 4 Participants |
Secondary
Change in Perifollicular Scale Assessments of Hairline Change by Study Physician
Scalp and hair exam and assessment with completion of grader survey to measure: Perifollicular scale Mild - affecting \<10% of scalp. Moderate - affecting 10-30% of scalp. Severe - affecting \>30% of scalp. For all signs other than Vellus/Intermediate/Terminal hair shafts: Percentage of types of hair shafts
Time frame: Baseline to month 6
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Change in Perifollicular Scale Assessments of Hairline Change by Study Physician | Improvement on trichoscopy: had a decrease in inflammatory signs | 13 Participants |
| Intervention | Change in Perifollicular Scale Assessments of Hairline Change by Study Physician | Combination of findings: Decrease in perifollicular scale | 6 Participants |
| Intervention | Change in Perifollicular Scale Assessments of Hairline Change by Study Physician | Combination of findings: Decrease in perifollicular hyperpigmentation and erythema | 13 Participants |
| Intervention | Change in Perifollicular Scale Assessments of Hairline Change by Study Physician | Combination of findings: Increased vellus hairs | 8 Participants |
| Intervention | Change in Perifollicular Scale Assessments of Hairline Change by Study Physician | Combination of findings: Decrease in disrupted honeycomb pigment network | 1 Participants |
| Intervention | Change in Perifollicular Scale Assessments of Hairline Change by Study Physician | Worsened disease on trichoscopy: Worsening perifollicular scale | 1 Participants |
| Intervention | Change in Perifollicular Scale Assessments of Hairline Change by Study Physician | Worsened disease on trichoscopy: Worsened erythema | 2 Participants |
| Intervention | Change in Perifollicular Scale Assessments of Hairline Change by Study Physician | Stable disease on trichoscopy: | 6 Participants |