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New treatment option for Androgenic Alopecia
Official title Androgenic Alopecia TH07 Clinical Trial
ClinicalTrials.gov ID: NCT07435012
What this study is testing
What is TH07?
TH07 is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for androgenic alopecia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn whether a new topical solution, TH07, can help treat androgenic alopecia in men and to learn more about its safety. Participants will be asked to apply either the TH07 solution, a standard hair growth treatment (Minoxidil 5%), or a placebo every day for 24 weeks.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 49, men only
You may be able to join if
- Males, 18 to 49 years of age on the date of enrollment.
- Presenting with androgenic alopecia measured as III vertex to V on Hamilton Norwood Scale.
- Body Mass Index (BMI) in the range of 19 to 35 kg/m2.
- Not administered any systemic or topical treatment for AGA during the last 90 days.
- Willing to comply with the following restrictions for the duration of trial participation:
You likely can't join if
- History of scalp treatment including though not limited to any of the following:
- Hair transplant or extension surgery.
- Hair weaving.
- Laser or light therapy on the scalp in the last 6 months.
- Micro-needling or intradermal therapy (mesotherapy) on the scalp including PRP in the last 6 months. 5-Any other surgical treatment for hair loss
- Any of the following hair styles: 1.Shaved scalp. 2-Use of occlusive wig, hair extensions, non- breathable wigs.
See the full eligibility criteria
- Males, 18 to 49 years of age on the date of enrollment.
- Presenting with androgenic alopecia measured as III vertex to V on Hamilton Norwood Scale.
- Body Mass Index (BMI) in the range of 19 to 35 kg/m2.
- Not administered any systemic or topical treatment for AGA during the last 90 days.
- Willing to comply with the following restrictions for the duration of trial participation:
- Any systemic or topical treatment of any system of medicine (other than trial treatment) for AGA.
- Hair dyes, hair texturizers, relaxers etc.
- Any new vitamins or nutritional supplements that are currently not being administered.
- Tattooing in the trial target area.
- Blood donations.
- OTC hair restorers.
- Do not expose your pregnant partner to your hands/skin where the drug might be present.
- Participation in any other drug or device trials during the course of this trial. Note: However, the following shall be permissible:
- Non-medicated \& anti-dandruff shampoos, scalp/hair applications including styling gels, sprays, mousse (styling gels, sprays, mousse etc. not to be used on the days of trial visits to the clinic.
- Current regimen (if any) of vitamins and nutritional supplements.
- Willing and able to provide written informed consent for participation in the trial and to comply with all trial requirements.
- Availability of and usage familiarity with a personal mobile phone (Android or iOS) with internet connectivity and a personal email address.
- History of scalp treatment including though not limited to any of the following:
- Hair transplant or extension surgery.
- Hair weaving.
- Laser or light therapy on the scalp in the last 6 months.
- Micro-needling or intradermal therapy (mesotherapy) on the scalp including PRP in the last 6 months. 5-Any other surgical treatment for hair loss
- Any of the following hair styles: 1.Shaved scalp. 2-Use of occlusive wig, hair extensions, non- breathable wigs.
- Known or presumed hypersensitivity to any trial treatment medication; history of anaphylaxis to drugs or allergic reactions in general, which in the opinion of investigator may affect the outcome of trial.
- Any other significant abnormalities indicating of severe, acute or chronic medical condition(s) that may lead to hair loss or otherwise interfere with the interpretation of trial results.
- History or likelihood of use of any of the specified medicines.
- History or clinical diagnosis of any of the specified medical conditions.
- Participation in any investigational or marketed drug or device trial in the last 90 days prior to screening for this trial.
- Any other condition that in the opinion of the investigator makes the patient unsuitable for inclusion in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 49 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.