A Pilot Randomized, Double-blind, Placebo-controlled Clinical Trial on the Efficacy and Safety of a Transdermal Gel that Delivers CO2 in the Treatment of Vulvovaginal Atrophy.

This prospective study aimed to assess the efficacy of a transdermal CO2 gel in promoting regeneration in the vulvovaginal area in postmenopausal women experiencing symptoms as part of genitourinary syndrome of menopause (GSM). Transdermal carboxytherapy refers to the application of CO2 through the skin's superficial layer, which is intended to increase oxygenation (through the Bohr effect) and angiogenesis, thus helping to reduce symptoms of GSM. In this study, 20 women with moderate or severe signs or symptoms of vulvovaginal atrophy were randomized to receive either transdermal CO2 therapy (n=10) or a placebo gel (ultrasound gel, n=10). The gels (transdermal CO2 gel or the placebo) were applied by the patients at home. The gels were applied in two treatment cycles (10 days of total treatment). Each cycle involved daily applications of the gel to the vulvovaginal area, from Monday to Friday, with no application on weekends. The Female Sexual Function Index (FSFI) and Day-to-Day Impact of Vaginal Aging (DIVA) questionnaires were used to gather standardized information, and biopsy samples were obtained from the vagina and vulva for histological analysis, both on the first day of treatment and 10 days after the final application of gel. Patients who received the transdermal CO2 gel showed significant improvements on the FSFI and DIVA questionnaires and the biopsies revealed that the CO2 gel had a regenerative effect on vulvovaginal tissues.

The Rationale for Photobiomodulation Therapy of Vaginal Tissue for Treatment of Genitourinary Syndrome of Menopause: An Analysis of Its Mechanism of Action, and Current Clinical Outcomes.

Objective: Light, particularly in the visible to far-infrared spectrum, has been applied to the female genital tract with lasers and other devices for nearly 50 years. These have included procedures on both normal and neoplastic tissues, management of condylomata, endometriosis, and menometrorrhagia, and, more recently, a number of fractional laser devices have been applied for the management of genitourinary syndrome of menopause (GSM) and stress urinary incontinence (SUI), and to achieve so-called vaginal rejuvenation. Photobiomodulation therapy (PBMT) has been proposed as an alternative for use in managing GSM and SUI. Methods: This article reviews the biological basis, symptoms, and management of GSM, and investigates the current status and rationale for the use of PBMT. Results and conclusions: Based on the preliminary evidence available, PBMT is safe and appears to be efficacious in treating GSM.

Clinical Prospective Study on the Use of Subcutaneous Carboxytherapy in the Treatment of Diabetic Foot Ulcer.

Diabetic footfoot ulcer (DFU) is a serious complication of diabetes mellitus, and possibly the major morbidity of the diabetic foot. It is the most common foot injury in diabetic patients and can lead to lower-extremity amputation. Management of DFU requires a systematic knowledge of the major risk factors for amputation, frequent routine evaluation, scrupulous preventive maintenance, and correction of peripheral arterial insufficiency. Carboxytherapy refers to the subcutaneous injection of CO2 to improve the microcirculation and promote wound-healing by stimulating the microcirculation. Since optimal ulcer-healing requires adequate tissue perfusion, it is considered that carboxytherapy could be useful in the treatment of DFU. The present prospective clinical study included 40 patients with different sizes and types of chronic DFU. In addition to cleaning of the wound, antibiotics and debridement as necessary, the treatment protocol included blood sugar control, medication, healthy habits, no weight-bearing, and carboxytherapy. The results showed that this treatment that included carboxytherapy promoted wound-healing and prevented amputation. These positive effects should be confirmed through a complete study that includes different clinical and instrumental parameters.

A Prospective Clinical and Instrumental Study on the Effects of a Transcutaneous Cosmeceutical Gel that is Claimed to Produce CO2.

Carboxytherapy is the therapeutic use of carbon dioxide (CO2) in its gaseous state. Since 1933, carboxytherapy has referred to either the subcutaneous injection of CO2 or percutaneous application in a warm bath. The present clinical study was performed to determine if there were any changes in the dermis after the application of a transcutaneous gel, which is claimed to produce CO2, and, if so, how these changes compared to those with CO2 injection. Ten patients received transcutaneous treatment with the gel on one side of the face and the other side without any product was used as a control. We used videocapillaroscopy with an optic probe (VCSO) to evaluate the changes in the microcirculation of the skin. VCSO was performed for the treated right and untreated left ear lobes in each patient. VCSO was performed before treatment was started (VCSO1) and after 7 days of treatment (VCSO2). A comparison of VCSO1 to VCSO2 showed an increase in the microcirculation, an increase in vertical and horizontal capillaries, and a reduction in the area of ischemia. These results are similar to those observed in other studies with CO2 injection. In conclusion, use of this transcutaneous CO2 gel produced changes in the dermis similar to those observed with subcutaneous injection of CO2.