Hypotrichosis
Conditions
Brief summary
A Prospective, single arm, and interventional Clinical Trial
Interventions
dermo cosmetic product like herbal or vitamin ingredients
Sponsors
Quantum Aesthetics Cosmetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Individuals of any sex and at least 18 years of age 2. Subjects who have inadequate eyebrow due to natural causes (eyebrow hypotrichosis) 3. A Grade 1 or 2 on the Global Eyebrow Assessment (GEBA) scale 4. Subjects who agree to forgo any additional treatment to the brows, such as waxing, plucking, threading and/or tinting, laser hair removal, and/or bleaching for the duration of the study. 5. Willing to complete all required study visits, procedures, and evaluations including photography.
Exclusion criteria
1. Subjects with any uncontrolled systemic disease (like systemic diseases which could prevent hair growth or produce abnormal growth) 2. known diagnoses possibly underlying or contributing to the state of the eyebrows including, but not limited to, telogen effluvium or anagen effluvium 3. Any known diseases, infection or abnormalities to the eyelid or eyebrow (including eczema, seborrheic dermatitis, alopecia areata, trichotillomania, thyroid diseases, atopic dermatitis, history of trauma or burn to the eyebrow region and etc.) 4. Subjects that have thinning brows as a result of over plucking, trichotillomania, chemotherapy or any other condition or treatment that causes hair loss. 5. Patients with permanent eyebrow loss due to over-grooming 6. Allergy to any component of the investigational product 7. Subjects with temporary or semipermanent eyebrow fillers, any permanent or semi-permanent tint, dye or bleaching within 3 months 8. Any skin pigmentation/depigmentation, microblading, tattoos, permanent eye and/or eyebrow make-up, moles, scars, or other characteristics within the eyebrow area 9. Subjects who used permanent injectable fillers in and around the eyebrow area within 12 months 10. Use of any over-the-counter or prescription eyebrow growth product within 3 months 11. Subjects who had undergone any facial surgery (e.g., brow lift) or eyebrow extension within 3 months of screening 12. Current enrollment in an investigational product or device or participation in such a study within 30 days 13. Aphakic subjects and/or pseudophakic subjects with a torn posterior lens capsule 14. Subjects with known risk factors for macular edema 15. Patients with a history of glaucoma and/or increased ocular pressure 16. Patients who are currently using an IOP-lowering prostaglandin analog 17. Previous cosmetic surgery to the upper face (e.g., periorbital surgery, brow lift, eyelid or eyebrow surgery, etc.). 18. Any planned facial cosmetic procedure that would interfere with the evaluation of the eyebrows 19. Participation in another investigational product or device study within the last 30 days 20. Females who are pregnant, nursing, or planning a pregnancy during the study, or who are of childbearing potential and not using a reliable method of contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with ≥ 1-grade increase in GEBA Score at month 5 | at 5 month |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects with ≥ 1-grade increase in the GEBA at month 2 | at month2 |
| Change from baseline in eyebrow diameter at month 2 and 5 (Based on DIA) | at month 2 and 5 |
| Change from baseline in eyebrow density at month 2 and 5 (Based on DIA) | at month 2 and 5 |
| The proportion of satisfied subjects (very satisfied/mostly satisfied) on Eyebrow Satisfaction Scale (ESS) Item 6 at month 2 and 5 | at month 2 and 5 |
| Adverse events reported from the baseline and during the study period (from the baseline up to week 20) | from the baseline up to week 20 |
Countries
Turkey (Türkiye)
Outcome results
None listed