Ireland
--:--IST
Active, not recruiting Not applicable

Effects of a Topical Serum Solution on Hair Characteristics

NCT07785869 · tracked via the Priya Life Science USA tracker
Sponsor
Pacagen, Inc
Phase
Not applicable
Started
2026-01-26
Last updated
2026-08-25

Condition(s) studied

Hair Characteristics

Investigational drug(s) / intervention(s)

Re:You Hair Revival Serum 1Re:You Hair Revival Serum 2Topical Minoxidil 2% →

Re:You Hair Revival Serum 1: Participants apply 1 mL (equivalent to two dropperfuls) of Re:You Hair Revival Serum 1 once daily to the scalp for 6 months.

Re:You Hair Revival Serum 2: Participants apply 1 mL (equivalent to two dropperfuls) of Re:You Hair Revival Serum 2 once daily to the scalp for 6 months.

Topical Minoxidil 2%: Participants apply 2 mL (equivalent to two dropperfuls) of topical minoxidil 2% solution once daily to the scalp for 6 months.

Study summary

The purpose of this study is to assess changes in the characteristics of scalp hair among healthy female participants with mild to moderate hair loss, classified as Ludwig Scale I-3 to II-2

Eligibility

Sex
FEMALE
Min age
35 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Participant is female between 35 and 70 years of age; 2. Participant has mild to moderate hair loss, classified as Ludwig Scale I-3 to II-2; 3. Participant agrees not to use any hair products other than those required by the protocol (tonic, lacquer, gel, foam, etc.) until the end of the study; 4. Participant agrees not to change their shampoo, conditioner, or shampooing frequency and maintain a consistent hairstyle for the duration of the study; 5. Participant is willing to use only their regular, neutral mascara on their eyelashes and stop use of any other products on them for the duration of the study; 6. Participant is willing to not substantially change their current diet, medications, multivitamins or supplement, or exercise routines for the duration of the study; 7. Participant is in generally good health; 8. Participant understands and has signed an Informed Consent Form in conformance with 21 CFR Part 50: "Protection of Human Participants." Exclusion Criteria: 1. Participant is pregnant, nursing, planning a pregnancy, or not using adequate birth control; 2. Participant wears a weave, extensions or dreadlocks or any other hairstyles that would interfere with the comb test; 3. Participant exhibits irritation, tattoos, sunburn, rashes, scratches, burn marks, scarring, etc. on the test site, which might interfere with evaluations of test results; 4. Participant is participating in another clinical study; 5. Participant has used Minoxidil, Finasteride or any topical and oral supplements or other therapies (such as light therapy) known to prevent or promote hair growth within the past 3 months; 6. Participant has been taking a stable dose of thyroid medication for a period of less than 4 months; 7. Participant has been taking a stable dose of GLP-1 (to manage diabetes or weight loss); 8. Participant has been taking a stable dose of hormonal medication (testosterone/ estrogen/progesterone) for a period of less than 6 months; 9. Participant has used any devices, prescriptions or OTC drugs that are known to affect the hair growth cycle within the past 6 months; 10. Participant uses medications known to affect the hair growth cycle within the last months such as cyproterone acetate, aldactone/spironolactone, finasteride, or other 5-alpha-reductase inhibitors; 11. Participant has received treatment with sympathomimetics, antihistamines, vasoconstrictors, non-steroidal anti-inflammatory agents, and/or systemic or topical corticosteroids within one month prior to initiation of the study; 12. Participant has a history of acute or chronic dermatologic, medical, and/or physical conditions which would, in the opinion of the Principal Investigator, could influence the outcome of the study; 13. Participant is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study; 14. Participant has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs; 15. Participant is currently undergoing treatment for active cancer of any kind; 16. Participant has uncontrolled diabetes.

Primary outcome measure(s)

  • Change from baseline in global scalp hair thickness/volume — Baseline, Day 180
    Clinical grading of the thickness of the global scalp hair using a 0-9 scoring scale

Trial sites (3)

FacilityCityRegionStatus
Eurofins | CRL, Cosmetics LLC Piscataway New Jersey
Eurofins Virginia Site Forest Virginia
Eurofins Consumer Product Testing (Guangzhou) Co., Ltd. Guangzhou Guangdong
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07785869 on ClinicalTrials.gov ↗ ← All trials in the USA