RosaceaPhase 4NCT06873087

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

A Phase 4 study testing İsotretinoin in people with Rosacea, run by SB Istanbul Education and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Rosacea
What is being tested?: İsotretinoin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Sep 2023to 30 Jun 2024
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

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Non-smokers
No excessive tea or coffee consumption (more than three times per week)
Non-alcohol consumers
No contraindications for systemic isotretinoin treatment

Who cannot join

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)

Show all 10Show fewer

Smokers
Excessive tea or coffee consumption (more than three times per week)
Alcohol consumers
Presence of contraindications for systemic isotretinoin treatment

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Istanbul Training and Research Hospital
Istanbul, fatih

Other trials in Turkey (Türkiye)

About this study

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

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

Read the 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.

Conditions: Rosacea
Being tested: İsotretinoin
Keywords: rosacea, isotretinoin, cgrp, vip, pacap, erythema index
Medical subject headings: Rosacea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06873087
Study group	Role	What they receive
Rosacea patients	Other	Patients with neuropeptide values calculated before and after isotretinoin treatment Receives: Drug: İsotretinoin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline, 1st month, 2nd month, and 3rd month of systemic isotretinoin treatment. ( 12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202330 Jun 2024

First posted12 Mar 2025
Study start1 Sep 2023
Primary completion30 Jun 2024
Study completion30 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for RosaceaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06873087
Sponsor's protocol ID: SBIstanbul_YMD
Status last verified: Mar 2025
First submitted: 1 Mar 2025
Last updated: 12 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Enrolling by invitation
Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions
Rosacea, Vascular Diseases
RecruitingPhase 2
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
Papulopustular Rosacea
Recruiting
Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy
Rosacea, Erythematotelangiectatic, Rosacea Subtype 1 (Erythematotelangiectatic)
RecruitingObservational study
Determinants of Chronic Inflammatory Skin Disease Trajectories
Atopic Dermatitis, Psoriasis

All Rosacea trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Alterations in PACAP, CGRP, and VIP Levels in Rosacea Patients Receiving Systemic Isotretinoin Treatment: Association with Erythema Index
ClinicalTrials.gov ID: NCT06873087
Acronym / sponsor ID: SBIstanbul_YMD
Conditions: Rosacea
Keywords: rosacea, isotretinoin, cgrp, vip, pacap, erythema index
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: SB Istanbul Education and Research HospitalUniversity, hospital or other
Study start: 1 Sep 2023 (actual)
Primary completion: 30 Jun 2024 (actual)
Study completion: 30 Jun 2024 (actual)
First posted: 12 Mar 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Participants will:

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Rosacea patients	Other	Drug: İsotretinoinPatients with neuropeptide values calculated before and after isotretinoin treatment

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
İsotretinoinIsotretinoin treatment at a dose of 0.3 mg/kg/day for 3 months	Drug	Rosacea patients

Primary outcome

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.
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.
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.

2 secondary outcomes

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)
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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
Individual participant dataSharing planned: Yes

Related trials for Rosacea

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Enrolling by invitation
Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions
Rosacea, Vascular Diseases
RecruitingPhase 2
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
Papulopustular Rosacea
Recruiting
Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy
Rosacea, Erythematotelangiectatic, Rosacea Subtype 1 (Erythematotelangiectatic)
RecruitingObservational study
Determinants of Chronic Inflammatory Skin Disease Trajectories
Atopic Dermatitis, Psoriasis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

yusuf m döş, MD principal investigator

Istanbul Training and Research Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing İsotretinoin in people with Rosacea, run by SB Istanbul Education and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06873087.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.