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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MMP with 5-FU infusion | Experimental | MMP with 5-FU infusion using tattoo device |
|
| MMP with saline infusion | Placebo Comparator | MMP with saline infusion using tattoo device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MMP with 5-FU | Drug | MMP with 5-FU using tattoo device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lesions counting of Idiopathic Guttate Hypomelanosis (IGH) | Two assessors will independently count the number of lesions in the treated skin area | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction assessed by Likert scale | self-administered | 30 days |
| Local adverse events | Frequency of patients presenting at least one local adverse event (ex:intense pain, scars, infection) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Dermatologica Arbache Ltda | Recruiting | São José dos Campos | São Paulo | 12245 760 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37011024 | Derived | Arbache S, Hirata SH. Efficacy and Safety of 5-Fluorouracil Tattooing to Repigment Idiopathic Guttate Hypomelanosis: A Split-Body Randomized Trial. Dermatol Surg. 2023 Jun 1;49(6):603-608. doi: 10.1097/DSS.0000000000003793. Epub 2023 Apr 3. |
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| ID | Term |
|---|---|
| D010787 | Photosensitivity Disorders |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D020782 | Matrix Metalloproteinases |
| D005472 | Fluorouracil |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| MMP with Saline infusion | Drug | MMP with saline infusion using tattoo device |
|
|
| 30 days |
| Systemic adverse events | Frequency of patients presenting at least one systemic adverse event (anaphylactic reaction) | 24 hours |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |