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Tests treatment safety and results for Alopecia Areata(AA)
Official title Cyclosporine Or Methotrexate for Pediatric Alopecia Areata: Routine Clinical Care Effectiveness Study
ClinicalTrials.gov ID: NCT07381556
What this study is testing
What is Methotrexate?
Methotrexate is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for alopecia areata(aa).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Rationale: Since the introduction of Janus kinase (JAK) inhibitors, there has been a significant advancement in the treatment of pediatric alopecia areata. Eligibility for this treatment, in the Netherlands, requires prior failure of systemic therapies such as cyclosporin or methotrexate.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age 2-17 years
- Clinical diagnosis of AA by a certified dermatologist
- Willingness of participant (in case 12-17 years) and parents to provide informed consent for participation in the study.
You likely can't join if
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Inability to adhere to the study protocol, including medication intake, clinic visits, and questionnaire completion.
- Patients who are ineligible for the CsA arm (due to contraindications), are automatically included in the MTX arm.
- Contra-indications CsA: Impaired kidney function. Poorly controlled hypertension Active infections. Presence of a malignancy. Nephrotic syndrome...
- Patients who are ineligible for the MTX arm (due to contraindications), are automatically included in the CsA arm.
- Contraindications MTX: Conception (both male and female) and lactation Severe kidney or liver dysfunction (fibrosis, cirrhosis) or alcohol abuse Bone...
The study team makes the final eligibility decision.
Where it's taking place
- Rotterdam, Netherlands
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rotterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.