Conventional Microneedling vs Microneedling With 5-FU (MMP) for Idiopathic Guttate Hypomelanosis (IGH) Repigmentation

Study Overview
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Brief Summary
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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.

Detailed Description
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Split body design. Each upper limb will receive a different intervention (experimental or placebo)

Official Title
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Conventional Microneedling Compared to Microneedling Associated With 5-FU Infusion (Microinfusion of Medication Into the Skin - MMP) for Idiopathic Guttate Hypomelanosis (IGH) Repigmentation

Conditions
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Photosensitivity Disorders

Intervention / Treatment
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* Drug: MMP with 5-FU
* Drug: MMP with Saline infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and females, between ages 30 and 70 Photodamaged skin on upper limbs with IGH lesions meeting aforementioned criteria and excluding differential diagnosis Fitzpatrick skin types III - V Apt and willing to comply with the entire program as well as appointments, treatment and examination Capable of understanding and providing a written informed consent Fertile women will have to use a viable birth control method for at least 3 months prior to entry and throughout the entire study Exclusion Criteria: Pregnancy, intention to become pregnant during the course of the study, less than 3 months after delivery or less than 6 weeks after breastfeeding cessation. Uncontrolled comorbidity or any disease that, in the investigator's opinion, may interfere with the treatment, healing or cure. Present symptoms of hormonal disturbances, as per the investigator's criteria. Constitutional photosensitivity or due to metabolic disfunction, or due to use of external agentes (pharmaco, natural products, etc.) prior to initial treatment or during the study. Use of oral isotretinoin 6 months prior to initial treatment or during the course of the study. Prior treatment in target área 3 months prior to initial treatment or during the course of the study. Adverse reaction to any external agentes (gel, lotions or anesthetic creams) required during the study in case no alternative is available for such agent. History of keloids or other type of hypertrophic scar formation or poor wound healing in a previously injured area of skin. History of collagen disease. Displastic nevus or suspicious carcinogenic lesion in área to be treated. Hemmorragic disorder or under anticoagulant medication, including the use of aspirin not permitting a minimum 10-day suspension prior to each treatment period (in accordance with the criteria of the patient's physician). Skin frailty of sensitivity, favoring hemmorrage. History of immunosuppresion / immunological deficiency disorders (including HIV infection) or use of immunosuppressant medication. Participation in a study involving medication or another device three months prior to the study or during enrollment herein. Any condition which, in the investigator's opinion, would jeopardize the study or its participants, such as acute psychiatric disorders, panic syndrome or any aversion to needles or to the procedure. Hypochromiant dermatoses such as vitiligo, pitiriasis, versicolor, albinism. Dermatoses that evolve like Koebner's phenomenon. Cutaneous infectious process at the application site.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MMP with 5-FU infusion<br>MMP with 5-FU infusion using tattoo device | Drug: MMP with 5-FU<br>* MMP with 5-FU using tattoo device<br>* Other names: MMP;|
| Placebo Comparator: MMP with saline infusion<br>MMP with saline infusion using tattoo device | Drug: MMP with Saline infusion<br>* MMP with saline infusion using tattoo device<br>* Other names: MMP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 30 days | 
| Systemic adverse events | Frequency of patients presenting at least one systemic adverse event (anaphylactic reaction) | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug delivery, Idiopathic Guttate Hypomelanosis