NCT07264153 Laser Therapy in the Isotretinoin-Induced Sacroiliitis
| NCT ID | NCT07264153 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Uşak University |
| Condition | Sacroilitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-11-24 |
| Primary Completion | 2026-04-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-11-24 with a primary completion date of 2026-04-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The clinical significance of this adverse effect lies in its impact on quality of life and the potential for misdiagnosis. The symptomatology can be severe enough to limit daily activities and may be mistakenly attributed to a primary rheumatic disease, leading to unnecessary long-term immunosuppressive therapy if the temporal link to isotretinoin is not identified. Therefore, a high index of suspicion is crucial for dermatologists, rheumatologists, and primary care physicians alike. Aim: To compare the effectiveness of High-Intensity Laser Therapy (HILT) in reducing pain intensity, in patients diagnosed with Isotretinoin-Induced Sacroiliitis.
Eligibility Criteria
Inclusion Criteria: * Aged between 18 and 35 years. * Receiving a stable dose of oral isotretinoin (e.g., 0.3-0.5 mg/kg/day) for at least one month. * Diagnosis of sacroiliitis based on: Clinical symptoms: Persistent (≥4 weeks) lower back/buttock pain, morning stiffness \>30 minutes, improvement with exercise. Positive physical findings: At least two positive sacroiliac joint provocation tests (e.g., FABER/Patrick's test, Gaenslen's test, Compression/Distraction test). Radiological confirmation (MRI): Active inflammation (bone marrow edema) on Short-Tau Inversion Recovery (STIR) sequences in one or both sacroiliac joints. * A baseline pain intensity of ≥4 on the Visual Analog Scale (VAS 0-10 cm). Exclusion Criteria: * ankylosing spondylitis or other seronegative spondyloarthritis * the presence of pregnancy * the presence of any cancer * the presence of multiple sclerosis
Contact & Investigator
Ali Y Karahan, Professor
PRINCIPAL INVESTIGATOR
Uşak University
Frequently Asked Questions
Who can join the NCT07264153 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 35 Years, studying Sacroilitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07264153 currently recruiting?
Yes, NCT07264153 is actively recruiting participants. Contact the research team at ali.karahan@usak.edu.tr for enrollment information.
Where is the NCT07264153 trial being conducted?
This trial is being conducted at Uşak, Turkey (Türkiye).
Who is sponsoring the NCT07264153 clinical trial?
NCT07264153 is sponsored by Uşak University. The principal investigator is Ali Y Karahan, Professor at Uşak University. The trial plans to enroll 50 participants.