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

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

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.

Study Overview

• Status: Unknown
• Conditions: Photosensitivity Disorders
• Intervention / Treatment: Drug: MMP with 5-FU; Drug: MMP with Saline infusion

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SÃO Paulo
    • São José Dos Campos, SÃO Paulo, Brazil, 12245 760
      • Recruiting
      • Clinica Dermatologica Arbache ltda
      • Contact: SAMIR ARBACHE; Phone Number: +55 12 39221400; Email: samir@dermocentro.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MMP with 5-FU infusion; MMP with 5-FU infusion using tattoo device	Drug: MMP with 5-FU; MMP with 5-FU using tattoo device; Other Names: 5-fluorouracil; drug delivery; drug infusion; microinfusion of medication percutaneously; MMP
Placebo Comparator: MMP with saline infusion; MMP with saline infusion using tattoo device	Drug: MMP with Saline infusion; MMP with saline infusion using tattoo device; Other Names: MMP

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Clinica Dermatologica Arbache ltda

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2016
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: August 26, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimate): September 19, 2016

Study Record Updates

• Last Update Posted (Actual): August 1, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: drug delivery; Idiopathic Guttate Hypomelanosis
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Photosensitivity Disorders; Hypopigmentation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Fluorouracil
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No