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

Clinica Dermatologica Arbache ltda

Status and phase

Unknown

Phase 4

Conditions

Photosensitivity Disorders

Treatments

Drug: MMP with Saline infusion

Drug: MMP with 5-FU

Study type

Interventional

Funder types

Other

Identifiers

NCT02904564

001

Details and patient eligibility

About

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.

Full description

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

Enrollment

30 estimated patients

Sex

All

Ages

30 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.