A Phase 4 interventional study of İsotretinoin in Rosacea, sponsored by SB Istanbul Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by SB Istanbul Education and Research Hospital · Phase 4, Interventional, and Treatment
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
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.
233 studies on the registry are indexed under Rosacea; 23 are open to participants now.
This study's enrollment of 30 is below the median of 61 across 200 interventional studies indexed under Rosacea.
Browse Rosacea studies →SB Istanbul Education and Research Hospital is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and at the end of the 3-month systemic isotretinoin treatment.
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.
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
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.
Time frame: Baseline, 1st month, 2nd month, and 3rd month of systemic isotretinoin treatment. ( 12 weeks)
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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SB Istanbul Education and Research Hospital