Cryo-Therapy - Lucencia Medical

Aesthetic Clinic ™

CryoCorrect PrecisionTM | Lucencia Medical

CryoCorrect PrecisionTM

CRYOTHERAPY DEVICE PROVEN EFFECTIVE FOR TARGETED SPOT REMOVAL

INTRODUCTION

Cryotherapy is the local or general exposure to low temperatures. In dermatology, cryotherapy is utilized to treat localized skin lesions including dark spots and skin tags. Traditional liquid nitrogen cryosurgery freezes tissue at a temperature of -321?F (-196?C), but has the potential to destroy healthy surrounding cells, causing adverse side effects. In contrast, carbon dioxide (CO2) can achieve effective cryo-necrosis at a milder temperature of -108?F (-78?C). This allows for a less aggressive tissue freeze that ruptures the cell membrane and destroys the cell, but is less likely to damage the surrounding tissue. Our results demonstrate that the SkinCeuticals CryoCorrect PRECISION™ device can safely and effectively treat localized benign skin lesions including skin tags, solar lentigines, and other cosmetic pigmented spots. Additionally, incorporating an integrated skin care regimen, consisting of Phloretin CF® serum following a CryoCorrect Treatment, has been proven to complement the post-treatment recovery process.

OBJECTIVE

To evaluate the tolerance and efficacy of the CryoCorrect PRECISION device as a stand-alone treatment and in conjunction with an integrated skin care regimen consisting of Phloretin CF serum.

CLINICAL METHODOLOGY

A 6-week, single-center, clinical study was conducted on 72 subjects. The subject population was divided into two cells depending on the skin lesion (dark spot or skin tag). Forty-four subjects were enrolled in cell 1 (dark spot), inclusive of sun spots/age spots/solar lentigines on the face or hand. Twenty-eight subjects were enrolled in cell 2 (skin tags on an area of the body). Efficacy and safety evaluations were conducted at baseline, immediate, days 1 and 3, and weeks 1, 2, 4, and 6. The skin tag evaluation completed at week 4. The dark spot evaluation completed at week 6.

Efficacy measures included visual evaluation and grading by the investigator, on a modified Griffith’s scale, of appearance of spot intensity and size (cell 1) and presence of tag and size (cell 2). Wound healing parameters, including epithelization, scabbing, smoothness, and general wound appearance, were also assessed through evaluation and grading by the investigator.

Cutaneous tolerability was evaluated by assessing subjective and objective irritation of the treatment area. Clinically-graded objective irritation parameters included erythema, dryness, scaling, and edema. In addition, subjects self-assessed burning, stinging, itching, tightness, and tingling.

Inclusion Criteria

Females aged 35–65
With or without self-perceived sensitive skin
Fitzpatrick I–III
Cell 1: Two similar sun spots/age spots/solar lentigines on the face or hand
Cell 2: One skin tag in an easily accessible area (for product application) on the body

PROTOCOL

A medical professional administered a one-time CryoCorrect Treatment to the skin lesion. Once daily, subjects applied Phloretin CF serum to the investigational area for 4 or 6 weeks depending on the cell. For cell 1, only one of the two investigational areas was treated with Phloretin CF serum. The support regimen for all subjects was limited to a sunscreen (Sheer Physical UV Defense SPF 50), applied to the investigational area daily.

RESULTS

One treatment with the CryoCorrect PRECISION demonstrated a statistically-significant decrease in the intensity and size of dark spots at weeks 2, 4, and 6 (Graph 1). By week 6, an improvement in dark spot intensity was observed in 98% of patients; an improvement in dark spot size was observed in 86% of patients. Sixty-six percent (66%) of subjects showed complete removal of their dark spot by week 6 (Figure 1).

One treatment with the CryoCorrect PRECISION demonstrated a statistically-significant decrease in the length and width of skin tags at weeks 1, 2, and 4 (Graph 2). Ninety-six (96%) of subjects showed complete removal of their skin tag by week 4 (Figure 2).

At week 1, the cell treated wtih the CryoCorrect PRECISION device and Phloretin CF serum demonstrated a statistically-significant improvement in skin smoothness and general appearance.

CONCLUSION

SkinCeuticials CryoCorrect PRECISION™is shown to have significant utility for targeted spot removal. Furthermore, the integration of Phloretin CF serum is proven to significantly complement the post-CryoCorrect Treatment recovery process.
The clinical study demonstrated:

significant reduction in the intensity and size of dark spots
significant decrease in the length and width of skin tags
significant improvement in smoothness and general appearance with the integration of Phloretin CF serum