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Clinical Trials/NCT03938948
NCT03938948UnknownNot Applicable

The Efficacy of Visible Red Light for Promoting the Growth of Human Scalp Hair for Both Male and Female - An Open-label Study

Awareable Technologies Inc1 site in 1 country62 target enrollmentStarted: April 11, 2019Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
62
Locations
1
Primary Endpoint
Hair Density
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

A total of 62 participants will receive red light (660 nm) to the scalp through a specially designed light therapy device integrated into a conventional hat. Each treatment will be 30 min per session applied on every other day for 14 weeks.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Male or female subjects between the ages of 18 and 60 years
  • •Diagnosed AGA in the past 12 months for male (Fitzpatrick I-IV, Hamilton-Norwood IIa-V ) and female (Fitzpatrick I-IV, and Ludwig-Savin Baldness Scale I-2, I-3, I-4, II-1, II-2 baldness patterns)

Exclusion Criteria

  • •Known Photosensitivity
  • •Using any oral or topical substance for hair growth
  • •Having Tattoo, hair transplantation, scalp reduction, malignancy or hair weave in the scalp are with alopecia
  • •Known medical conditions that could negatively affect hair growth, such as infections, connective tissue disease
  • •Currently or plan to be on a calorie-restricted diet during study participation

Arms & Interventions

Treatment Arm

Experimental

62 participants shall be enrolled

Intervention: low-level laser/light therapy (Device)

Outcomes

Primary Outcomes

Hair Density

Time Frame: 14 weeks

Individual participant's hair density will be measured at the end of 14 weeks and compared with the baseline density measure at the start of the treatment.

Secondary Outcomes

  • Hair Follicle Change(14 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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