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OpenTrials
Completed

NCT Number: NCT07776028

Efficacy and Safety of Dallixa® Eyelash Serum in Idiopathic Eyelash Hypotrichosis

Efficacy and Safety of Dallixa® Eyelash Serum in Idiopathic Eyelash Hypotrichosis

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Akdeniz Üniversitesi Hastanesi

Antalya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals of any sex and at least 18 years of age
  • Subjects who have inadequate eyelashes due to natural causes (Idiopathic eyelash hypotrichosis)
  • Eyelash prominence assessment of minimal or moderate
  • A score of 1 or 2 on the clinician-graded Global Eyelash Assessment (GEA)
  • Willing to complete all required study visits, procedures, and evaluations including photography.

Exclusion criteria

  • Subjects with unequal right and left eyelashes or no visible eyelashes
  • Damage to eyelid area (scarring) that may prevent growth of eyelashes
  • Any uncontrolled systemic disease
  • 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)
  • 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)
  • Any permanent eyeliner or implants of any kind, or anticipated use of false eyelashes
  • Any semi-permanent eyelash tint, dye, curl, or eyelash extension application within 3 months
  • Use of any over-the-counter or prescription eyelash growth product within 3 months
  • Use of treatments which may affect hair growth (eg, minoxidil, chemotherapy) within 6 months
  • Unable or unwilling to keep contact lenses out during product application and for 30 minutes after application
  • Severe hyperpigmentation around the eye
  • Allergy to any component of the investigational product
  • 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
  • Current enrollment in an investigational product or device or participation in such a study within 30 days

Treatment and study plan

dermo cosmetic product

Drug

dermo cosmetic products like herbal or vitamin ingredients

Primary outcomes

  1. The proportion of subjects with ≥ 1-grade increase in the GEA at month 4

    Time frame: 4 month

Secondary outcomes

  1. The proportion of subjects with ≥ 1-grade increase in the GEA at month 2

    Time frame: 2month

  2. The proportion of subjects with ≥ 2-grade increase in the GEA at month 2 and 4

    Time frame: at2 and4 month

  3. Change from baseline in upper eyelash length (mm) at month 2 and 4 (Based on DIA)

    Time frame: at 2 and 4 month

  4. Change from baseline in average progressive upper eyelash thickness (mm2) at month 2 and 4 (Based on DIA)

    Time frame: at 2 and 4 month

  5. 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

    Time frame: at 2 and4 month

  6. Adverse events reported from the baseline and during the study period (from the baseline up to week 16)

    Time frame: from the baseline up to week 16

Sponsors and collaborators

Lead sponsor

Quantum Aesthetics Cosmetics

Industry

Registry information

Official study title

Evaluation of the Efficacy and Safety of Dallixa® Eyelash Serum (Produced by Quantum Aesthetics Cosmetics, Turkey) in Subjects With Idiopathic Eyelash Hypotrichosis

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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