Published Papers
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1
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
(PubMed) Leibaschoff GH, Arrieta CTN, Reyes CLG, Melamed JL. Surg Technol Int. 2021 May 20;38:234-239. doi: 10.52198/21.STI.38.GY1350.PMID: 33878192 Clinical Trial.
Abstract
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.
2
Gyn-Aesthetic: the ‘new normal’ after COVID-19
Gustavo H Leibaschoff
2
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
(PubMed) Photomed Laser Surg. 2019 July, 37 (7 ): 395-407
Raymond J Lanzafame 1, Sarah de la Torre 2, Gustavo H Leibaschoff 3
Abstract
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.
Keywords: collagen; genitourinary syndrome of menopause; photobiomodulation; stress urinary incontinence; tissue regeneration and healing; vagina; womens’ health.
3
In response to the FDA warning about the use of photomedicine in gynecology
(PubMed) Juan José Escribano, Pablo González-Isaza, Konstantinos Tserotas, Stavros Athanasiou, Nicola Zerbinati, Gustavo Leibaschoff, Stefano Salvatore, Rafael Sánchez-Borrego
Laser Med Sci.2019 Sep;34(7):1509-1511. Doi: 10.107.Epub2019 M
Abstract
To alert patients and health care providers about the use of energy-based devices to perform a vaginal “rejuvenation,” cosmetic vaginal procedures, or nonsurgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function, the US Food and Drug Administration (FDA) has issued a warning about the effectiveness and safety of such devices. We agree with the FDA that certain devices (laser, radiofrequency, etc.) have been marketed inappropriately for uses that are outside of their cleared or approved intended uses. We want to position ourselves in the strict training of professionals so that the indications and techniques are used in the best possible way, knowing that, similar to any medical or surgical technique, the side effects can appear in the short and long term, and should be recognized and remedied.
Keywords: Energy-based devices; FDA safety communication; Vaginal cosmetic procedures; Vaginal ‘rejuvenation’.
4
Genitourinary syndrome of menopause and the role of biostimulation with non-cross-linked injectable hyaluronic acid plus calcium hydroxyapatite
(PubMed) I P González, G Leibaschoff, C Esposito, G Cipolla, A Bader, T Lotti, M Tirant, N Van Thuong, M RamoAbdulkader, R Rauso, D Serafin, A Vojvodic, N ZerbinatiJ Biol RegulHomeost Agents. Nov-Dec 2019;33(6)
Keywords: genitourinary; menopause; vulvovaginal atrophy.
5
Clinical Prospective Study on the Use of Subcutaneous Carboxytherapy in the Treatment of Diabetic Foot Ulcer
( PubMed) Lynda Khiat, Gustavo H Leibaschoff
Surg Technol Int. 2018 Jun 1; 32:81-90
Abstract
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.
6
A Prospective Clinical and Instrumental Study on the Effects of a Transcutaneous Cosmeceutical Gel that is Claimed to Produce CO₂
(PubMed) Surg Technol Int. 2018 Jun 1 2018 ; 32:33-45. Gustavo H Leibaschoff, Luis Coll, Wendy E Roberts
Abstract
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.
7
Transcutaneous Temperature Controlled Radiofrequency (TTCRF) for the Treatment of Menopausal Vaginal/Genitourinary Symptoms
(PubMed) Gustavo Leibaschoff, Pablo Gonzalez Izasa, Jose Luis Cardona, John R Miklos, Robert D Moore. Surg Technol Int. 2016 Oct 26; 29: 149 – 159
Abstract
Objective: The aim of this study was to evaluate the effects of non-ablative, monopolar transcutaneous temperature controlled radiofrequency (TTCRF) technology in the treatment of postmenopausal women suffering from genuine stress urinary incontinence (SUI) related to menopause and to evaluate histological changes vaginally associated with the treatment.
Materials and methods: Subjective and objective symptoms of SUI were assessed in study subjects before and after TTCRF, (1 treatment every 30 days, for 3 months; n=10) and compared with the effects of a placebo treatment on a control group of demographically similar women (n =10). SUI was subjectively evaluated with subjective Urogenital Distress Inventory (UDI-6) and with the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) before and after TTCRF treatments and objectively with cough stress test. Vaginal health was evaluated with the Vaginal Health Index (VHI) score and visual analogue score (VAS) for dyspareunia and dryness. Punch biopsies were obtained at the urethra-vesical junction in the anterior compartment, before and at the end of the treatment protocol. Basic and histochemical staining methods were used.
Results: In subjects suffering SUI, TTCRF treatment was associated with a significant (p<0.01) improvement of ICIQ-SF and UDI-6 scores. Seven of 10 patients (70%) had a negative cough stress test after the treatment protocol. Improvements were maintained up to the 12th week of follow-up. The results were supported by the positive histologic changes seen vaginally in women suffering from postmenopausal vaginal atrophy. TTCRF was well tolerated with no complications reported in study patients.
Conclusion: TTCRF treatment in postmenopausal women suffering from SUI showed significant improvement in both objective and subjective symptoms. Vaginal health scores also improved as did VAS for dryness and dyspareunia. We feel these improvements were related to histological changes related to improvement in vaginal atrophy that were not observed in placebo patients.
8
Guidelines for autologous fat grafting and PRP
(Chapter) Gustavo Leibaschoff – ICAM USA
Female genital plastic and cosmetic surgery. April 2016. Michael Goodman.
9
Use of Ultrasound-Assisted Liposuction for the Treatment of Breast Hypertrophy, Surgical Clinical Prospective Study on 45 Cases
(PubMed) Medical & Clinical Research, 2020. Gustavo Leibaschoff. Pilar Reyes
10
25 Surgical Treatment: Liposuction, Liposculpture, and Lipoplasty
Basic and Clinical Dermatology, 2010
Gustavo Leibaschoff
11
Cellulite PATHOPHYSIOLOGY AND TREATMENT Second edition 2009
Second edition 2009 (Book) Gustavo Leibaschoff. Pier Antonio Bacci
12
Mesotherapy for Cosmetic Periocular Enhacement
Dr S Lam, Dr Gustavo Leibaschoff
January 2008. Cosmetic Oculoplastic Surgery pp 409-410
13
Pathophysiology of Cellulite
14
Preliminary Study to Verify the Transdermal Delivery of a Micronized Gel with Active Ingredients Using DermaWave “ No Needle Mesotherapy ” ( NNM )
Dr Gustavo Leibaschoff
Abstract
An instrumental study using radioisotope lymphography was carried out to determine the effectiveness of the DermaWave No-Needle Mesotherapy device. The DermaWave device utilizes techniques of molecule delivery called threshold electroporation and ‘Aquaphoresis’ facilitating transdermal delivery of different topical active ingredients. The active ingredients are encapsulated in a standardized, micronized gel specifically designed to be used with the device. The study objective was to monitor absorption of the gel ingredients to a specific depth in tissue and to determine if the active ingredients were present after absorption in the lymphatic system of patients with Edematous Fibrosclerotic Panniculopathy (Cellulite).
15
Lymphatics and Liposculpture
Abstract
Introduction: Although lymphatic drainage of the lower extremities is well understood and liposuction-assisted lypectomy has been in existence almost 25 years, this study was undertaken to determine if liposculpture of the lower extremities causes significant damage to the lymphatics. Materials and Methods: One patient with bitrochanteric lipodystrophy was selected for the study. Radioisotopic lymphography was performed.
16
Efficacy of the Different Types of Reciprocating Cannulas: A Comparative Clinical and Surgical Research Study
17
Noninvasive Assessment of the Effectiveness of Cellasene in Patients with Edematous Fibrosclerotic Panniculopathy (Cellulitis): A Double-Blind Prospective Study
December 2001. International Journal of Cosmetic Surgery and Aesthetic Dermatology 3(4):265-273. Dr Gustavo Leibaschoff
18
Anatomic-Radiologic Comparison of the Effects of Liposculpture on the Lymphatic System of the Lower Extremities
The American Journal of Cosmetic Surgery, 2000. Dr Gustavo Leibaschoff
Abstract
A study of the lymphatic anatomy of the leg was performed using lymphography. Methods of visualization of the lymphatic anatomy are discussed and include radiographic visualization during surgery and direct examination of tissues after injection of vital dyes. Using these methods, the effect of liposuction on the lymphatics of the leg was studied in a single patient. Results of this preliminary study indicate that liposuction of the lower
19
Noninvasive Assessment of the Effectiveness of Cellasene in Patients with Edematous Fibrosclerotic Panniculopathy (Cellulitis): A Double-Blind Prospective Study
December 2001. International Journal of Cosmetic Surgery and Aesthetic Dermatology 3(4):265-273. Dr Gustavo Leibaschoff, Dr. Luis R. Coll, Dr. Juan G. Desimone
20
Cellulite (liposclerosis): etiology and treatment
The American journal of Cosmetic Surgery, 1997. Dr Gustavo Leibaschoff
Abstract
This article discusses in detail the pathophysiology of liposclerosis (cellulite). Clinical classifications, phytotherapeutic medications, and treatment methods are tabulated and discussed. Lymphoedema is identified as a major factor in the etiology of cellulite formation. The causes of lymphoedema with fibrosclerosis and dermal retraction as they relate to the formation of cellulite are presented.
21
Ultrasonic Liposculpture: Its Use in the Treatment of Liposclerosis December 1993
The American Journal of Cosmetic Surgery 10(4):239-241 – DOI:10.1177/074880689301000403 –
Dr Gustavo Leibaschoff