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

NCT06873087 | Completed Phase 4 FDA Drug

• 1 other identifier: SBIstanbul_YMD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Rosacea

Keywords

rosacea; isotretinoin; cgrp; vip; pacap; erythema index

Outcome Measures

Primary Outcomes (3)

• Change in PACAP Levels in Rosacea Patients 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

  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

  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 Outcomes (2)

• 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)

• 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)

Study Arms (1)

Rosacea patients

OTHER

Patients with neuropeptide values calculated before and after isotretinoin treatment

Drug: İsotretinoin

Interventions

İsotretinoin DRUG

Isotretinoin treatment at a dose of 0.3 mg/kg/day for 3 months

Rosacea patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SB Istanbul Education and Research Hospital: lead

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, fatih, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rosacea

Interventions

Isotretinoin

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• yusuf m döş, MD

  Istanbul Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 12, 2025
• Study Start: September 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

TU (1)