deltatrials
Completed NA INTERVENTIONAL 3-arm NCT00947219

Treatment of Androgenic Alopecia in Males

A Randomized, Double-Blind, Control Device Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 9 & 12 Beam Models: For the Treatment of Androgenetic Alopecia in Males

Sponsor: Lexington International, LLC

Updated 8 times since 2017 Last updated: Dec 21, 2012 Started: Jul 31, 2009 Primary completion: Aug 31, 2010 Completion: Aug 31, 2010
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00947219, this NA trial focuses on Androgenetic Alopecia and Hair Loss and remains completed. Sponsored by Lexington International, LLC, it has been updated 8 times since 2009, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

This is randomized, double-blind, control device clinical study across 3 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair). The trial will involve approximately 75 male subjects who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types I-IV, with classifications of Norwood-Hamilton IIa to V, have active hair loss within the last 12 months. Subjects will use the device on three non-consecutive days a week as directed per device for 26 weeks treatment duration. Safety analysis will be assessed based on the reports of adverse events during study.

This is randomized, double-blind, control device clinical study across 3 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).

The trial will involve approximately 75 male subjects who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types I-IV, with classifications of Norwood-Hamilton IIa to V, have active hair loss within the last 12 months.

Subjects will use the device on three non-consecutive days a week as directed per device for 26 weeks treatment duration.

Safety analysis will be assessed based on the reports of adverse events during study.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed NA

  2. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  3. Jan 2023 — Jul 2024 [monthly]

    Completed NA

  4. Dec 2022 — Jan 2023 [monthly]

    Completed NA

  5. Jan 2021 — Dec 2022 [monthly]

    Completed NA

Show 3 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Completed NA

  2. Feb 2017 — Jun 2018 [monthly]

    Completed NA

  3. Jan 2017 — Feb 2017 [monthly]

    Completed NA

    First recorded

Jul 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Lexington International, LLC
Data source: Lexington International, LLC

For direct contact, visit the study record on ClinicalTrials.gov .