Changes in PACAP, CGRP, and VIP Levels in Rosacea Patients on Systemic Isotretinoin and Their Ass… (NCT06873087) | Clinical Trial Compass
CompletedPhase 4
Changes in PACAP, CGRP, and VIP Levels in Rosacea Patients on Systemic Isotretinoin and Their Association with Erythema
Turkey (Türkiye)30 participantsStarted 2023-09-01
Plain-language 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in PACAP Levels in Rosacea Patients at the End of the 3-Month Systemic Isotretinoin Treatment
Timeframe: Baseline and at the end of the 3-month systemic isotretinoin treatment.
2
Change in CGRP Levels in Rosacea Patients at the End of the 3-Month Systemic Isotretinoin Treatment
Timeframe: Baseline and at the end of the 3-month systemic isotretinoin treatment.
3
Change in VIP Levels in Rosacea Patients at the End of the 3-Month Systemic Isotretinoin Treatment
Timeframe: Baseline and at the end of the 3-month systemic isotretinoin treatment.
Trial details
NCT IDNCT06873087
SponsorSB Istanbul Education and Research Hospital