HORMONES IN VERNAL KERATOCONJUNCTIVITIS

Conjunctivitis, Vernal Clinical Trial

— HOR-VKC-2020  

Official title:

HORMONAL ROLE IN VERNAL KERATOCONJUNCTIVITIS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05038241
• Other study ID #: 1965
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2021
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Allergic
• Conjunctivitis, Vernal
• Keratoconjunctivitis

Locations

Country	Name	City	State
Italy	dr. Daniele Giovanni Ghiglioni	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	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.
Secondary	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.	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.	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.
Secondary	To assess the correlation between serum hormone levels and VKC activity.	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.	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.
Secondary	To evaluate the possible presence of a serum hormone marker that may be related to the resolution of ocular symptoms.	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.	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.