A Phase 4 interventional study of MMP with 5-FU and MMP with Saline infusion in Photosensitivity Disorders, sponsored by Clinica Dermatologica Arbache ltda. Status unknown at 1 site in Brazil. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-01.
Sponsored by Clinica Dermatologica Arbache ltda · Phase 4, Interventional, and Treatment
The purpose of this study is to determine whether 5-FU infusion (Microinfusion of Medicine Percutaneously - MMP) is effective for Idiopathic Guttate Hypomelanosis (IGH) repigmentation compared to conventional Microneedling. MMP is a procedure done with tattoo devices using medication in place of ink.
Split body design. Each upper limb will receive a different intervention (experimental or placebo)
25 studies on the registry are indexed under Photosensitivity Disorders; 4 are open to participants now.
This study's planned enrollment of 30 is below the median of 38 across 18 interventional studies indexed under Photosensitivity Disorders.
Browse Photosensitivity Disorders studies →Clinica Dermatologica Arbache ltda is the lead sponsor of 5 studies on the registry; 2 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.
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Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
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The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMP with 5-FU infusion using tattoo device
Drug: MMP with 5-FU
MMP with saline infusion using tattoo device
Drug: MMP with Saline infusion
Drug page: Fluorouracil
MMP with 5-FU using tattoo device
Also known as: 5-fluorouracil, drug delivery, drug infusion, microinfusion of medication percutaneously, MMP
MMP with saline infusion using tattoo device
Also known as: MMP
Lesions counting of Idiopathic Guttate Hypomelanosis (IGH)
Two assessors will independently count the number of lesions in the treated skin area
Time frame: 30 days
Patient satisfaction assessed by Likert scale
self-administered
Time frame: 30 days
Local adverse events
Frequency of patients presenting at least one local adverse event (ex:intense pain, scars, infection)
Time frame: 30 days
Systemic adverse events
Frequency of patients presenting at least one systemic adverse event (anaphylactic reaction)
Time frame: 24 hours
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2016 (actual). Primary completion is estimated for Jan 2020, 41 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fluorouracil
Clinica Dermatologica Arbache ltda