Radio-Frequency Microneedling Device

Feasibility Study of a Novel Cooling Device for Pain Management During Treatment of Skin With Radio-Frequency Microneedling Device

The specific aims of the study are as follows:

Aim 1. Using the EC device, evaluate the cooling rate of in vivo tissue and the temperature profile of the tissue with various pre-cooling times (Phase 1).

Aim 2. Using the EC device, evaluate the cooling time that is required to provide analgesia during RF microneedling at different energies (Phase 2).

Aim 3. Evaluate the pain management capability of the EC device compared to the TEC device during RF microneedling when using topical anesthesia only (Phase 2).

Aim 4. Determine if the EC device can eliminate the need for tumescent anesthesia and/or topical anesthesia prior to RF microneedling (Phase 2).

Aim 5. Evaluate the operability and ease of use of the EC device for clinicians (Phase 2).

In this research study we want to learn more about an experimental cooling method, evaporative cooling (EC), compared to the currently used thermoelectric cooling (TEC) for pain management during radiofrequency (RF) microneedling treatments. This study will use the Profound® RF microneedling device, manufactured by Candela, with a dermal handpiece which will have the experimental cooling plate attachment.

We will recruit and screen up to 30 subjects with the goal of having 6 subjects complete Phase 1 and 12 subjects complete Phase 2 of the study. Phase 2 of the study was not enrolled.

Inclusion Criteria:

• Signed informed consent to participate in the study
• Female subjects, ≥ 18 and ≤ 60 years of age at the time of enrollment
• Fitzpatrick Skin Type I to III
• Not pregnant or lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment
• Negative urine pregnancy test prior to treatment
• General good health confirmed by medical history and skin examination of the area to be treated
• Willing to receive the Profound RF microneedling treatment
• Willing to follow the treatment and post-treatment care instructions
• Willing to have photographs and videos taken of the treated areas to be used de-identified in evaluations, publications and presentations
• Subjects must be able to read and understand English.

Exclusion Criteria:

• Subject has had a surgical procedure(s) in the intended area of treatment in the last 6 months
• Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
• Known allergy to lidocaine, 3 or more antibiotics, or glycerol.
• Active malignancy or history of malignancy in the past 5 years.
• Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
• Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any disease state that in the opinion of the Principal Investigator would interfere with the topical anesthetic, treatment or healing process).
• Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion)
• Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
• History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medication.
• Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen.
• History of significant lymphatic drainage problems.
• History of cancer which required lymph node biopsy or dissection.
• Suffering from significant skin conditions in treatment areas or inflammatory skin condition, including but not limited to open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Principal Investigator's discretion) or during the treatment course.
• History of keloid scarring, abnormal wound healing, forming marked post-inflammatory hyper or hypopigmentation, and /or prone to bruising.
• History of epidermal or dermal disorders (particularly if involving collagen or micro vascularity) including collagen vascular disease or vasculitic disorders.
• Use of isotretinoin (Accutane) within 6 months of treatment or during study.
• Subject on systemic corticosteroid therapy 6 months prior to or during the study.
• Dysplastic nevi in the area to be treated.
• Subject has palpable lymphadenopathy at any visit. Standard palpation techniques will be used.
• Subjects with history of severe edema.
• Subject is unable or unwilling to comply with the study requirements.
• Subject is currently enrolled or has been enrolled within the prior 3 months in a clinical study of any other unapproved investigational drug or device.
• Any other condition that would, in the professional opinion of the investigator, potentially affect the integrity of the data or would pose an unacceptable risk to the subject.
• Known history of cold urticaria.
• Fitzpatrick skin type IV - VI