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

March 6, 2025 updated by: Yusuf Mert Döş, SB Istanbul Education and Research Hospital

Alterations in PACAP, CGRP, and VIP Levels in Rosacea Patients Receiving Systemic Isotretinoin Treatment: Association with Erythema Index

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey
        • Istanbul Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Rosacea patients
Patients with neuropeptide values calculated before and after isotretinoin treatment
Drug: İsotretinoin
Isotretinoin treatment at a dose of 0.3 mg/kg/day for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PACAP Levels in Rosacea Patients at the End of the 3-Month Systemic Isotretinoin Treatment
Time Frame: 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.
Baseline and at the end of the 3-month systemic isotretinoin treatment.
Change in CGRP Levels in Rosacea Patients at the End of the 3-Month Systemic Isotretinoin Treatment
Time Frame: 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.
Baseline and at the end of the 3-month systemic isotretinoin treatment.
Change in VIP Levels in Rosacea Patients at the End of the 3-Month Systemic Isotretinoin Treatment
Time Frame: 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.
Baseline and at the end of the 3-month systemic isotretinoin treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Rosacea Area and Severity Index (RASI) throughout the 3-month systemic isotretinoin treatment
Time Frame: 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.
Baseline, 1st month, 2nd month, and 3rd month of systemic isotretinoin treatment. ( 12 weeks)
Change in Erythema Index throughout the 3-month systemic isotretinoin treatment
Time Frame: 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.
Baseline, 1st month, 2nd month, and 3rd month of systemic isotretinoin treatment. ( 12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SB Istanbul Education and Research Hospital

Investigators

  • Principal Investigator: yusuf m döş, MD, Istanbul Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

March 1, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBIstanbul_YMD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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