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

Inclusion Criteria:

• Healthy males and females, between ages 30 and 70

• Photodamaged skin on upper limbs with IGH lesions meeting aforementioned criteria andexcluding differential diagnosis

• Fitzpatrick skin types III - V

• Apt and willing to comply with the entire program as well as appointments, treatmentand 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 monthsprior to entry and throughout the entire study

Exclusion Criteria:

• Pregnancy, intention to become pregnant during the course of the study, less than 3months after delivery or less than 6 weeks after breastfeeding cessation.

• Uncontrolled comorbidity or any disease that, in the investigator's opinion, mayinterfere 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 ofexternal agentes (pharmaco, natural products, etc.) prior to initial treatment orduring the study.

• Use of oral isotretinoin 6 months prior to initial treatment or during the course ofthe study.

• Prior treatment in target área 3 months prior to initial treatment or during thecourse of the study.

• Adverse reaction to any external agentes (gel, lotions or anesthetic creams) requiredduring the study in case no alternative is available for such agent.

• History of keloids or other type of hypertrophic scar formation or poor wound healingin 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 aspirinnot permitting a minimum 10-day suspension prior to each treatment period (inaccordance with the criteria of the patient's physician).

• Skin frailty of sensitivity, favoring hemmorrage.

• History of immunosuppresion / immunological deficiency disorders (including HIVinfection) or use of immunosuppressant medication.

• Participation in a study involving medication or another device three months prior tothe study or during enrollment herein.

• Any condition which, in the investigator's opinion, would jeopardize the study or itsparticipants, such as acute psychiatric disorders, panic syndrome or any aversion toneedles 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.