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

Phase 4

Completed

• Conditions: Rosacea
• Interventions: Drug: İsotretinoin

• Registration Number: NCT06873087
• Lead Sponsor: SB Istanbul Education and Research Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2023-09-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2025-03
• Study First Submitted: 2025-03-01
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Study First Posted: 2025-03-12
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rosacea patients	İsotretinoin	Patients with neuropeptide values calculated before and after isotretinoin treatment

Primary Outcome Measures

Name	Time	Method
Change in PACAP Levels in Rosacea Patients at the End of the 3-Month Systemic Isotretinoin Treatment	Baseline and at the end of the 3-month systemic isotretinoin treatment.	This study examines the change in PACAP levels in rosacea patients at the end of a 3-month systemic isotretinoin treatment. Blood samples are collected at baseline and after 3 months of treatment to assess the potential effects of isotretinoin on PACAP regulation. The study aims to explore the role of PACAP in the pathogenesis of rosacea and evaluate whether isotretinoin influences its expression in circulation.
Change in CGRP Levels in Rosacea Patients at the End of the 3-Month Systemic Isotretinoin Treatment	Baseline and at the end of the 3-month systemic isotretinoin treatment.	This study examines the change in CGRP levels in rosacea patients at the end of a 3-month systemic isotretinoin treatment. Blood samples are collected at baseline and after 3 months of treatment to assess the potential effects of isotretinoin on CGRP regulation. The study aims to explore the role of CGRP in the pathogenesis of rosacea and evaluate whether isotretinoin influences its expression in circulation.
Change in VIP Levels in Rosacea Patients at the End of the 3-Month Systemic Isotretinoin Treatment	Baseline and at the end of the 3-month systemic isotretinoin treatment.	This study examines the change in VIP levels in rosacea patients at the end of a 3-month systemic isotretinoin treatment. Blood samples are collected at baseline and after 3 months of treatment to assess the potential effects of isotretinoin on VIP regulation. The study aims to explore the role of VIP in the pathogenesis of rosacea and evaluate whether isotretinoin influences its expression in circulation.

Secondary Outcome Measures

Name	Time	Method
Change in Rosacea Area and Severity Index (RASI) throughout the 3-month systemic isotretinoin treatment	Baseline, 1st month, 2nd month, and 3rd month of systemic isotretinoin treatment. ( 12 weeks)	This study evaluates the Rosacea Area and Severity Index (RASI) change throughout a 3-month systemic isotretinoin treatment in patients with papulopustular rosacea (PPR). RASI scores are assessed at baseline and at the first, second, and third months of treatment to monitor the progression of lesion severity over time. The study aims to provide objective data on isotretinoin's efficacy in reducing rosacea severity and to explore its potential effects beyond papulopustular lesions.
Change in Erythema Index throughout the 3-month systemic isotretinoin treatment	Baseline, 1st month, 2nd month, and 3rd month of systemic isotretinoin treatment. ( 12 weeks)	This study investigates the Erythema Index (EI) change throughout a 3-month systemic isotretinoin treatment in patients with papulopustular rosacea (PPR). EI measurements are taken at baseline, 1st, 2nd, and 3rd months using a Mexameter device to assess erythema severity over time. The study aims to evaluate the impact of isotretinoin on erythema and explore its potential effects on vascular and inflammatory responses in rosacea.

Trial Locations

Locations (1)

Istanbul Training and Research Hospital; 🇹🇷 Istanbul, Fatih, Turkey