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

NCT02904564 | Unknown Phase 4 DMC

• 1 other identifier: 001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Photosensitivity Disorders

Keywords

drug delivery; Idiopathic Guttate Hypomelanosis

Outcome Measures

Primary Outcomes (1)

• Lesions counting of Idiopathic Guttate Hypomelanosis (IGH)

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

  30 days

Secondary Outcomes (3)

• Patient satisfaction assessed by Likert scale

  30 days

• Local adverse events

  30 days

• Systemic adverse events

  24 hours

Study Arms (2)

MMP with 5-FU infusion

EXPERIMENTAL

MMP with 5-FU infusion using tattoo device

Drug: MMP with 5-FU

MMP with saline infusion

PLACEBO COMPARATOR

MMP with saline infusion using tattoo device

Drug: MMP with Saline infusion

Interventions

MMP with 5-FU DRUG

MMP with 5-FU using tattoo device

Also known as: 5-fluorouracil, drug delivery, drug infusion, microinfusion of medication percutaneously, MMP

MMP with 5-FU infusion

MMP with Saline infusion DRUG

MMP with saline infusion using tattoo device

Also known as: MMP

MMP with saline infusion

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Dermatologica Arbache ltda: lead

Study Sites (1)

Clinica Dermatologica Arbache Ltda

São José dos Campos, São Paulo, 12245 760, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 37011024 DERIVED

MeSH Terms

Conditions

Photosensitivity Disorders

Interventions

Matrix Metalloproteinases; Fluorouracil; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: September 19, 2016
• Study Start: August 20, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: August 1, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)