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OpenTrials
Completed

NCT Number: NCT07775989

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

A Prospective, single arm, and interventional Clinical Trial

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

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 eyebrow due to natural causes (eyebrow hypotrichosis)
  • A Grade 1 or 2 on the Global Eyebrow Assessment (GEBA) scale
  • 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.
  • Willing to complete all required study visits, procedures, and evaluations including photography.

Exclusion criteria

  • Subjects with any uncontrolled systemic disease (like systemic diseases which could prevent hair growth or produce abnormal growth)
  • known diagnoses possibly underlying or contributing to the state of the eyebrows including, but not limited to, telogen effluvium or anagen effluvium
  • 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.)
  • Subjects that have thinning brows as a result of over plucking, trichotillomania, chemotherapy or any other condition or treatment that causes hair loss.
  • Patients with permanent eyebrow loss due to over-grooming
  • Allergy to any component of the investigational product
  • Subjects with temporary or semipermanent eyebrow fillers, any permanent or semi-permanent tint, dye or bleaching within 3 months
  • Any skin pigmentation/depigmentation, microblading, tattoos, permanent eye and/or eyebrow make-up, moles, scars, or other characteristics within the eyebrow area
  • Subjects who used permanent injectable fillers in and around the eyebrow area within 12 months
  • Use of any over-the-counter or prescription eyebrow growth product within 3 months
  • Subjects who had undergone any facial surgery (e.g., brow lift) or eyebrow extension within 3 months of screening
  • Current enrollment in an investigational product or device or participation in such a study within 30 days
  • Aphakic subjects and/or pseudophakic subjects with a torn posterior lens capsule
  • Subjects with known risk factors for macular edema
  • Patients with a history of glaucoma and/or increased ocular pressure
  • Patients who are currently using an IOP-lowering prostaglandin analog
  • Previous cosmetic surgery to the upper face (e.g., periorbital surgery, brow lift, eyelid or eyebrow surgery, etc.).
  • Any planned facial cosmetic procedure that would interfere with the evaluation of the eyebrows
  • Participation in another investigational product or device study within the last 30 days
  • 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

Treatment and study plan

dermo cosmetic product

Other

dermo cosmetic product like herbal or vitamin ingredients

Primary outcomes

  1. The proportion of subjects with ≥ 1-grade increase in GEBA Score at month 5

    Time frame: at 5 month

Secondary outcomes

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

    Time frame: at month2

  2. Change from baseline in eyebrow diameter at month 2 and 5 (Based on DIA)

    Time frame: at month 2 and 5

  3. Change from baseline in eyebrow density at month 2 and 5 (Based on DIA)

    Time frame: at month 2 and 5

  4. The proportion of satisfied subjects (very satisfied/mostly satisfied) on Eyebrow Satisfaction Scale (ESS) Item 6 at month 2 and 5

    Time frame: at month 2 and 5

  5. Adverse events reported from the baseline and during the study period (from the baseline up to week 20)

    Time frame: from the baseline up to week 20

Sponsors and collaborators

Lead sponsor

Quantum Aesthetics Cosmetics

Industry

Registry information

Official study title

Efficacy and Safety of Dallixa® Eyebrow Serum in Eyebrow 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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