Thulium Laser and Topical Platelet Rich Plasma (PRP) vs. PRP Injection for the Treatment of Male … (NCT05129254) | Clinical Trial Compass
WithdrawnNot Applicable
Thulium Laser and Topical Platelet Rich Plasma (PRP) vs. PRP Injection for the Treatment of Male Androgenetic Alopecia
Stopped: Study not initiated.
0Started 2022-07-01
Plain-language summary
The objective of this clinical study is to compare the safety and efficacy of a laser and topically applied platelet-rich plasma vs. platelet rich plasma injection in the treatment of male-pattern hair loss. Participating subjects will receive up to four (4) monthly treatments and will have a 12 month follow-up period.
Who can participate
Age range18 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy male, ≥ 18 years of age at time of informed consent, seeking treatment for hair loss.
* 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. (Norwood Hamilton Class 3-4 for males)
* Able to read, understand and voluntarily provide written informed consent.
* 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.
Exclusion Criteria:
* 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.
* 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 p…
What they're measuring
1
Percentage of subjects with score of 2 or 3 on Clinician Global Aesthetic Improvement (CGAIS) scale at month 7 follow-up.
Timeframe: 7 months
2
Percentage of subjects with score of 2 or 3 on Subject Global Aesthetic Improvement at month 7 follow-up.