Conventional Microneedling vs Microneedling With 5-FU (MMP) for Idiopathic Guttate Hypomelanosis (IGH) Repigmentation
Conventional Microneedling vs Microneedling With 5-FU (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.
Split body design. Each upper limb will receive a different intervention (experimental or
 placebo)
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.