Hypotrichosis
Conditions
Brief summary
Efficacy and Safety of Dallixa® Eyelash Serum in Idiopathic Eyelash Hypotrichosis
Interventions
dermo cosmetic products like herbal or vitamin ingredients
Sponsors
Quantum Aesthetics Cosmetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A Prospective, single arm, and interventional Clinical Trial
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 eyelashes due to natural causes (Idiopathic eyelash hypotrichosis) 3. Eyelash prominence assessment of minimal or moderate \- A score of 1 or 2 on the clinician-graded Global Eyelash Assessment (GEA) 4. Willing to complete all required study visits, procedures, and evaluations including photography.
Exclusion criteria
1. Subjects with unequal right and left eyelashes or no visible eyelashes 2. Damage to eyelid area (scarring) that may prevent growth of eyelashes 3. Any uncontrolled systemic disease 4. Any disease, infection, or abnormality of the eye or in the area around the eye and the current use of ophthalmic medication (glaucoma, uveitis, eye infections, chronic blepharitis or severe dry eye) 5. Any ocular (eye or eyelid) surgery within 3 months or anticipated need for ocular surgery during the study (including laser, refractive, intraocular filtering surgery, blepharoplasty) 6. Any permanent eyeliner or implants of any kind, or anticipated use of false eyelashes 7. Any semi-permanent eyelash tint, dye, curl, or eyelash extension application within 3 months 8. Use of any over-the-counter or prescription eyelash growth product within 3 months 9. Use of treatments which may affect hair growth (eg, minoxidil, chemotherapy) within 6 months 10. Unable or unwilling to keep contact lenses out during product application and for 30 minutes after application 11. Severe hyperpigmentation around the eye 12. Allergy to any component of the investigational product 13. 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 14. Current enrollment in an investigational product or device or participation in such a study within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with ≥ 1-grade increase in the GEA at month 4 | 4 month |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects with ≥ 1-grade increase in the GEA at month 2 | 2month |
| The proportion of subjects with ≥ 2-grade increase in the GEA at month 2 and 4 | at2 and4 month |
| Change from baseline in upper eyelash length (mm) at month 2 and 4 (Based on DIA) | at 2 and 4 month |
| Change from baseline in average progressive upper eyelash thickness (mm2) at month 2 and 4 (Based on DIA) | at 2 and 4 month |
| Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9) at month 2 and 4 | at 2 and4 month |
| Adverse events reported from the baseline and during the study period (from the baseline up to week 16) | from the baseline up to week 16 |
Countries
Turkey (Türkiye)
Outcome results
None listed