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Completed

NCT Number: NCT05038241

HORMONES IN VERNAL KERATOCONJUNCTIVITIS

VKC is more common in males and tends to resolve with pubertal development. Clinical observation was not followed by an investigation that clarified whether there is a correlation between the hormonal pattern and the evolution of the disease, in particular it is not defined whether there is a correlation between the hormonal pattern and the resolution of the disease.

This study aims to evaluate the hormonal pattern in patients with VKC and, in particular, the possible role of these hormones in the resolution of this condition in puberty.

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Key information

Conditions

Conjunctivitis, Vernal Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

10 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

dr. Daniele Giovanni Ghiglioni

Milan, 20122, Italy

About this study

The study presents a retrospective and prospective transversal observational design, non-pharmacological, monocentric, non-profit.

It is based on the collection of clinical, laboratory and therapy data on databases of patients affected by Vernal keratoconjunctivitis.

Participation in the study will be proposed to parents of patients with VKC over 10 years of age at puberty (B2 according to Tanner for females and G2 according to Tanner for males), based on endocrinological evaluation. Patients, differentiated by gender, will be divided into two groups: patients with active VKC and patients with resolved VKC. Both study groups will be offered a blood sample to determine the serum levels of LH, FSH, estradiol, DHEAS, androstenedione, total testosterone, SHBG, DHT, 17OH-progesterone, TSH-R, albumin, ACTH and cortisol. In postpuberal females, the sample must be taken in the first 5 days of the menstrual cycle.

This study provides for the enrollment of patients diagnosed with VKC followed at the Allergy Outpatient Clinic of the UOSD Pediatrics High Intensity of Care - IRCCS Ca 'Granda Foundation Ospedale Maggiore Policlinico di Milano. The source documentation of the data will be the medical record and the reports of the examinations, provided for by the study, performed at the Institute. On the same day, a blood sample and a pubertal stage assessment will be performed. An allergy / ophthalmological examination for VKC will be carried out only if it had not been performed in the 12 months prior to the execution of the blood sample. There is no follow-up.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of VKC assessed by an allergologist or ophthalmologist over 10 years of age

Exclusion criteria

  • Presence of pre-existing pathologies of the endocrine system.

Treatment and study plan

Primary outcomes

  1. To assess the difference in serum total testosterone levels between the population of subjects with active VKC and the population of subjects with resolved VKC.

    Time frame: All subjects enrolled between April 2021 and October 2021 undergo a venous blood sample for the determination of plasma testosterone. This withdrawal is made in the morning, between 8.30 and 9.30 am, in a single determination at the time of enrollment.

    A venous blood sample is taken from all enrolled subjects for the determination of plasma testosterone. This collection is made in the morning, between 8.30 and 9.30 am.

Secondary outcomes

  1. To evaluate the difference in serum levels of the other hormones investigated between the population of subjects with active VKC and the population of subjects with resolved VKC.

    Time frame: All subjects enrolled between April 2021 and October 2021 undergo a venous blood sample for the determination of plasma hormones. This withdrawal is made in the morning, between 8.30 and 9.30 am, in a single determination at the time of enrollment.

    A venous blood sample is taken from all enrolled subjects for the determination of hormones. This collection is made in the morning, between 8.30 and 9.30 am.

  2. To assess the correlation between serum hormone levels and VKC activity.

    Time frame: All subjects enrolled between April 2021 and October 2021 undergo a venous blood sample for plasma hormones. This withdrawal is made in the morning, between 8.30 and 9.30 am, in a single determination at the time of enrollment.

    A venous blood sample is taken from all enrolled subjects for the determination of plasma hormones. This collection is made in the morning, between 8.30 and 9.30 am. VKC activity is determined by an allergologic evaluation at the time of enrollment.

  3. To evaluate the possible presence of a serum hormone marker that may be related to the resolution of ocular symptoms.

    Time frame: All subjects enrolled between April 2021 and October 2021 undergo a venous blood sample for plasma hormones. This withdrawal is made in the morning, between 8.30 and 9.30 am, in a single determination at the time of enrollment.

    A venous blood sample is taken from all enrolled subjects for the determination of plasma hormones. This collection is made in the morning, between 8.30 and 9.30 am. VKC activity is determined by an allergologic evaluation at the time of enrollment.

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study title

HORMONAL ROLE IN VERNAL KERATOCONJUNCTIVITIS

Acronym: HOR-VKC-2020

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 9, 2021
Registry last updated
Apr 22, 2022

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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