Trial Outcomes & Findings for A Study of Revian Red All LED Cap as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (NCT NCT05759338)

NCT ID: NCT05759338

Last Updated: 2025-08-11

Results Overview

Photographs of the stabilization and regrowth of the hairline documented by standardized camera and dermatoscopic photographs of the scalp

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: Baseline to month 6
• Results posted on: 2025-08-11

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	24
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

A Study of Revian Red All LED Cap as a Novel Treatment for Central Centrifugal Cicatricial Alopecia

Baseline characteristics by cohort

Measure	Intervention n=24 Participants 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.
Age, Continuous	56.79 years STANDARD_DEVIATION 10.87 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	24 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	24 Participants n=5 Participants
Disease Duration	11.75 years STANDARD_DEVIATION 8.27 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to month 6

Photographs of the stabilization and regrowth of the hairline documented by standardized camera and dermatoscopic photographs of the scalp

Outcome measures

Measure	Intervention n=21 Participants 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.
Shape of the Hairline Documented With Photographs stabilization of hair loss	8 Participants
Shape of the Hairline Documented With Photographs improvement in hair growth	12 Participants
Shape of the Hairline Documented With Photographs worsened hair loss	2 Participants

SECONDARY outcome

Timeframe: Baseline to month 6

Population: Secondary outcome (Alleviation of signs and symptoms of disease):

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.

Outcome measures

Measure	Intervention n=21 Participants 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.
Change in Hairline Assessment Scores by Participant Improvement in symptoms:	11 Participants
Change in Hairline Assessment Scores by Participant Worsened symptoms	6 Participants
Change in Hairline Assessment Scores by Participant • Stable symptoms	4 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Intervention n=21 Participants 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.
Change in Perifollicular Scale Assessments of Hairline Change by Study Physician Combination of findings: Decrease in perifollicular scale	6 Participants
Change in Perifollicular Scale Assessments of Hairline Change by Study Physician Improvement on trichoscopy: had a decrease in inflammatory signs	13 Participants
Change in Perifollicular Scale Assessments of Hairline Change by Study Physician Combination of findings: Decrease in perifollicular hyperpigmentation and erythema	13 Participants
Change in Perifollicular Scale Assessments of Hairline Change by Study Physician Combination of findings: Increased vellus hairs	8 Participants
Change in Perifollicular Scale Assessments of Hairline Change by Study Physician Combination of findings: Decrease in disrupted honeycomb pigment network	1 Participants
Change in Perifollicular Scale Assessments of Hairline Change by Study Physician Worsened disease on trichoscopy: Worsening perifollicular scale	1 Participants
Change in Perifollicular Scale Assessments of Hairline Change by Study Physician Worsened disease on trichoscopy: Worsened erythema	2 Participants
Change in Perifollicular Scale Assessments of Hairline Change by Study Physician Stable disease on trichoscopy:	6 Participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amy McMichael

Wake Forest University Health Sciences

Phone: 704-355-2000

Email: Amy.Mcmichael@Advocatehealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place