Changes in PACAP, CGRP, and VIP Levels in Rosacea Patients on Systemic Isotretinoin and Their Association with Erythema

SB Istanbul Education and Research Hospital

Status and phase

Completed

Phase 4

Conditions

Rosacea

Treatments

Drug: İsotretinoin

Study type

Interventional

Funder types

Other

Identifiers

NCT06873087

SBIstanbul_YMD

Details and patient eligibility

About

The goal of this clinical study is to investigate the effects of systemic isotretinoin on vasoactive neuropeptides (PACAP, VIP, CGRP) and its relationship with the erythema index in patients with rosacea. It also aims to assess the clinical efficacy of isotretinoin in reducing rosacea severity. The main questions this study seeks to answer are:

Does systemic isotretinoin treatment lead to changes in PACAP, VIP, and CGRP levels in rosacea patients? How does isotretinoin affect erythema and overall rosacea severity? Researchers will compare pre- and post-treatment neuropeptide levels and erythema index measurements to determine the effects of isotretinoin.

Participants will:

Take 0.3 mg/kg/day of isotretinoin for three months Undergo monthly clinical evaluations with RASI and erythema index measurements Have blood samples collected at baseline and after treatment to assess changes in PACAP, VIP, and CGRP levels

Full description

This clinical study investigates the effects of systemic isotretinoin on vasoactive neuropeptides (PACAP, VIP, CGRP) and its relationship with erythema severity in rosacea patients. The study aims to explore the potential role of these neuropeptides in rosacea pathogenesis and assess isotretinoin's impact beyond its known effects on papulopustular lesions.

A total of 30 patients with papulopustular rosacea (PPR) and 35 healthy controls are included in the study. Participants are evaluated before treatment and at the 1st, 2nd, and 3rd months of isotretinoin therapy. Lesion severity is assessed using the Rosacea Area and Severity Index (RASI), while erythema is objectively measured with a Mexameter device. Blood samples are collected at baseline and after three months of treatment to determine PACAP, VIP, and CGRP levels.

The study is designed to provide an objective assessment of neuropeptide levels in relation to erythema severity in rosacea and to explore potential mechanisms underlying isotretinoin's effects. Findings from this research may contribute to further investigations into VIP-targeted therapeutic strategies for erythema management in rosacea.

Enrollment

30 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients aged 18 to 75 years with a diagnosis of papulopustular rosacea (PPR)
No history of systemic or topical medication use for rosacea or other dermatological conditions in the past four weeks
No known autoimmune or dysregulated systemic disease
No history of migraine, inflammatory bowel disease or malignancy
No daily sun exposure exceeding three hours
No excessive spice consumption (more than three times per week)
Non-smokers
No excessive tea or coffee consumption (more than three times per week)
Non-alcohol consumers
No contraindications for systemic isotretinoin treatment

Exclusion criteria

Patients younger than 18 or older than 75 years or without a diagnosis of papulopustular rosacea (PPR)
History of systemic or topical medication use for rosacea or other dermatological conditions in the past four weeks
Presence of a known autoimmune or dysregulated systemic disease
History of migraine, inflammatory bowel disease, or malignancy
Daily sun exposure exceeding three hours
Frequent spice consumption (more than three times per week)
Smokers
Excessive tea or coffee consumption (more than three times per week)
Alcohol consumers
Presence of contraindications for systemic isotretinoin treatment