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

Phase 4

• Conditions: Photosensitivity Disorders
• Interventions: Drug: MMP with Saline infusion; Drug: MMP with 5-FU

• Registration Number: NCT02904564
• Lead Sponsor: Clinica Dermatologica Arbache ltda

Brief Summary

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

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

Study Timeline

• Study Start: 2016-08-20
• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-19
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-08-01
• Primary Completion: 2020-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MMP with saline infusion	MMP with Saline infusion	MMP with saline infusion using tattoo device
MMP with 5-FU infusion	MMP with 5-FU	MMP with 5-FU infusion using tattoo device

Primary Outcome Measures

Name	Time	Method
Lesions counting of Idiopathic Guttate Hypomelanosis (IGH)	30 days	Two assessors will independently count the number of lesions in the treated skin area

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction assessed by Likert scale	30 days	self-administered
Systemic adverse events	24 hours	Frequency of patients presenting at least one systemic adverse event (anaphylactic reaction)
Local adverse events	30 days	Frequency of patients presenting at least one local adverse event (ex:intense pain, scars, infection)

Trial Locations

Locations (1)

Clinica Dermatologica Arbache Ltda; 🇧🇷 São José Dos Campos, SÃO Paulo, Brazil