Clinical trial for Androgenic Alopecia
Official title Dual Modality Treatment of Androgenic Alopecia With KeraFactor® Solution and Revian® LED Light Therapy
ClinicalTrials.gov ID: NCT07810504
What this study is testing
- What it's testing
- This single-center, prospective, randomized, placebo-controlled interventional study will evaluate the safety and efficacy of KeraFactor scalp-stimulating solution and the Revian Red wireless smart cap, alone and in combination, for the treatment of female androgenic alopecia. Forty female subjects aged 35 to 55 with clinically diagnosed androgenic alopecia will be randomized into four treatment arms and followed for 24 weeks.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 55, women only
You may be able to join if
- Female participants aged 35 to 55 years, inclusive.
- Clinically diagnosed with androgenic alopecia.
- Fitzpatrick Skin Types I-VI.
- Willingness to undergo baseline laboratory screening, including CBC, TSH, iron/TIBC, 25-hydroxyvitamin D, ferritin, free testosterone, total...
- Generally healthy individuals with no significant dermatological conditions affecting the scalp, such as eczema, psoriasis, or folliculitis, that...
You likely can't join if
- Presence of autoimmune or pathologic causes of hair loss, such as alopecia areata or lichen planus.
- Active scalp disorders or infections, such as eczema, psoriasis, seborrheic dermatitis, or folliculitis.
- Clinically significant abnormalities in baseline screening labs, including CBC, TSH, iron/TIBC, 25-hydroxyvitamin D, ferritin, free testosterone...
- History of hypersensitivity to any components of KeraFactor scalp-stimulating solution.
- Presence of a medical condition that makes the skin sensitive to sun or light, or use of photosensitizing medications, shampoos, lotions, or other...
- Medical conditions or medications known to significantly affect hair growth, including uncontrolled thyroid disorders, anemia, cancer, chemotherapy...
See the full eligibility criteria
Who can join
- Female participants aged 35 to 55 years, inclusive.
- Clinically diagnosed with androgenic alopecia.
- Fitzpatrick Skin Types I-VI.
- Willingness to undergo baseline laboratory screening, including CBC, TSH, iron/TIBC, 25-hydroxyvitamin D, ferritin, free testosterone, total testosterone, estradiol (E2), and FSH, to confirm eligibility and...
- Generally healthy individuals with no significant dermatological conditions affecting the scalp, such as eczema, psoriasis, or folliculitis, that could interfere with treatment assessment.
- Willingness to maintain a consistent hair care routine and refrain from new hair treatments, supplements, or grooming practices that could confound study results.
- Willingness and ability to provide recent laboratory results to establish baseline metabolic parameters.
- Participants must have a smartphone or tablet that operates on iOS version 11.0 or higher and/or Android 9.0 or higher, access to the Apple App Store or Google Play to download the REVIAN app, and internet or wireless...
- Commitment to avoid hair dryer use for at least 48 hours before and after each office visit.
- Commitment to avoid hair extensions for at least 6 months prior to and throughout the study duration.
- Ability and willingness to adhere to the study protocol, including scheduled visits and assessments.
- Willingness to allow trichoscopic and photographic documentation of the scalp and hair.
- Ability and willingness to provide written informed consent after being fully informed about the study's nature, purpose, procedures, potential risks, and benefits.
What rules you out
- Presence of autoimmune or pathologic causes of hair loss, such as alopecia areata or lichen planus.
- Active scalp disorders or infections, such as eczema, psoriasis, seborrheic dermatitis, or folliculitis.
- Clinically significant abnormalities in baseline screening labs, including CBC, TSH, iron/TIBC, 25-hydroxyvitamin D, ferritin, free testosterone, total testosterone, E2, and FSH, that fall outside satisfactory ranges...
- History of hypersensitivity to any components of KeraFactor scalp-stimulating solution.
- Presence of a medical condition that makes the skin sensitive to sun or light, or use of photosensitizing medications, shampoos, lotions, or other therapies that sensitize the skin to light.
- Medical conditions or medications known to significantly affect hair growth, including uncontrolled thyroid disorders, anemia, cancer, chemotherapy, spironolactone, 5-alpha-reductase inhibitors, or cyproterone.
- Active use of GLP-1 receptor agonists, such as Ozempic, Wegovy, Mounjaro, Zepbound, or similar medications.
- Active use of topical treatments for hair regrowth, such as minoxidil or finasteride.
- Pregnant, breastfeeding, or planning to become pregnant during the study.
- Unrealistic expectations or psychological conditions that may impact study compliance or satisfaction.
- Continual use of red-light or low-level laser therapy outside of study requirements.
- Recent initiation of topical hair regrowth treatments, such as minoxidil or finasteride.
- Continual use of minoxidil, finasteride, or other hair regrowth treatments.
- Any active cancer or cancer diagnosis.
- Active smoking habit.
- History of hair transplant procedures.
- Significant scalp scarring or structural anomalies in treatment zones.
- Recent major surgeries or medical interventions within the last 3 months.
- History of prolonged or repeated mechanical tension on the hair or scalp, such as tight hairstyles contributing to traction alopecia.
The study team makes the final eligibility decision.
Where it's taking place
- Pasadena, California, United States
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 female, 35 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pasadena, California, United States. 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.