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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: Split body design. Each upper limb will receive a different intervention (experimental or placebo)
Sponsor: Clinica Dermatologica Arbache ltda

Current Primary Outcome: Lesions counting of Idiopathic Guttate Hypomelanosis (IGH) [ Time Frame: 30 days ]

Two assessors will independently count the number of lesions in the treated skin area


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Clinica Dermatologica Arbache ltda

Dates:
Date Received: August 26, 2016
Date Started: August 2016
Date Completion: February 2017
Last Updated: September 13, 2016
Last Verified: September 2016