Modulated Light Therapy in Participants with Pattern Hair Loss

Phase 3

Completed

• Conditions: Androgenic Alopecia; Human Genetics and Inherited Disorders - Other human genetics and inherited disorders; Skin - Dermatological conditions

• Registration Number: ACTRN12617000775314
• Lead Sponsor: Five Corners Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-26
• Study Completion: 2019-05-27
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

The study population will consist of adult men and women between 18 and 65 years of age with diagnosis of Androgenic Alopecia, consistent with males who have Norwood Hamilton Classification IIa to V patterns of hair loss and females who have Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal, both with Fitzpatrick Skin Types I – IV. Participants agree to undergo all study procedures including global photographs of hair loss/growth, placement of a 1 mm tattoo dot placed on the scalp for macrophotography, refrain from using all other hair growth products or treatments (oral or topical medication including over the counter herbal medications, or Dutasteride), avoid the use of wigs, hairpieces, and/or hair extensions during the study, return for all the required follow-up visits, and in the opinion of the Clinical Investigator, are able to understand this clinical investigation and cooperate with the investigational procedures.

Exclusion Criteria

Participants with 12 month history of taking Propecia or any other hair growth supplements including Rogaine or Minoxidil based products for 6-months prior to enrollment, having previous hair transplant, cell treatment, micro-needling, tattooing, or any other treatment to the scalp, suffering from an active autoimmune disease such as serum lupus erythematosus or alopecia areata, photosensitivity to visible light, currently suffering from a dermatological condition in the treatment area or has a significant scar in the hair treatment area that will make hair growth difficult (such as a systemic burn, malignancy, etc.), has a sensitivity or allergy to tattoo ink, using any medication deemed to inhibit hair growth as determined by the physician investigator, or have had radiation or chemotherapy in the last 12 months will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy outcome of this study is mean change in hair count from baseline. Standardized Canfield macro-photographs will be taken to capture digital images at baseline and will be compared to images captured at various endpoints throughout the study. Multiple images will be taken at each endpoint and will be reviewed by independent blinded observers to conduct the hair count. [Primary endpoint is 16-weeks follow-up from the initial application at baseline.]

Secondary Outcome Measures

Name	Time	Method
Quantitative Scalp Hair Growth: Changes in terminal hair count. Terminal hair counts (non-vellus/non-miniaturized greater than or equal to 0.03 mm) will be assessed in the target region with macrophotography.[Quantitative Scalp Hair Growth at 8 and 26 weeks over baseline];Physician's Global Assessment (PGA): Determination of hair growth over baseline through global photographic review by blinded reviewer(s).[PGA at 8-weeks, 16-weeks, and 26-weeks];Hair Specific Skindex-29 Quality of Life Score by participants.[Hair Specific Skindex-29 QOL Score at 8-, 16- and 26-weeks. ]