Status:
WITHDRAWN
Thulium Laser and KeraFactor for the Treatment of Androgenetic Alopecia
Lead Sponsor:
Montefiore Medical Center
Conditions:
Androgenetic Alopecia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The objective of this clinical study is to assess the safety and efficacy of using a laser and hair growth factors in the treatment of male-pattern hair loss. Participating subjects will receive up to...
Detailed Description
This is a single-center, open-label, baseline-controlled, study evaluating the use of a Thulium laser (1927nm) and post-treatment topically applied KeraFactor, which contain hair-stimulating growth fa...
Eligibility Criteria
Inclusion
- Subject must voluntarily sign and date an IRB approved informed consent form
- Subjects with diagnosis of androgenetic alopecia with hair loss recorded over the past 6 months. (Ludwig Savin Scale: Class I-4, II-1, II-2 for females and Norwood Hamilton Class 3-4 for males
- Able to read, understand and voluntarily provide written informed consent.
- Healthy male or female, ≥ 18 years of age at time of informed consent up to 65 years of age, seeking treatment for hair loss.
- Subject is determined to be healthy, non-smoker who agrees not to make any changes to their daily hair treatment regime during the study.
- Subjects able and willing to comply with the treatment protocol and follow-up schedule and requirements.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
- Women of child-bearing age are required to be using a reliable, non-hormonal method of birth control for the duration of the study. Subjects will be asked to have a negative Urine Pregnancy test at baseline.
Exclusion
- Subjects does not have the capacity to consent to the study
- Subject has other types of alopecia of the scalp (i.g., alopecia areata, scarring alopecia)
- Use of minoxidil or 5-alpha reductase inhibitors (i.e., finasteride, dutasteride) 3 months prior to screening date.
- Any medical condition that in the consideration of the investigator, would present an increased risk of a photosensitivity reaction to the subject.
- Pregnant in the last 12 months, intending to become pregnant, postpartum or nursing in the last 12 months.
- Any previous surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 months.
- History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection), and/or any history of systemic chemotherapy for prior 12 months.
- History or current use of the following prescription medications: Immunosuppressive medications/biologics, 6 months prior to and during the study. Accutane or other systemic retinoids within the past twelve months.
- Smoking or vaping in the past 12 months.
- History of hyperlipidemia, diabetes mellitus, hepatitis, or bleeding disorders.
- History of major depressive disorders or endocrine disorders including but not limited to; hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism as well as Polycystic Ovarian Syndrome (PCOS) in females.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04882969
Start Date
September 1 2021
End Date
December 31 2024
Last Update
August 12 2021
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10467