Phototherapy and Radiofrecuency for Cellulite

NCT05441917 | Suspended DMC

• 1 other identifier: 11062022
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Cellulite is a condition that consists of an edematous infiltration of connective tissue. It has multiple factors in its etiology, making it difficult to choose just one type of treatment. Thus, aiming at greater therapeutic efficiency, the association of therapies is studied. This research aims to evaluate the Sanae method for the treatment of cellulite. The sample will feature 60 participants who have different degrees of cellulite. Initially, a pilot study will be carried out with 12 patients, divided into two groups: G1-P: 6 volunteers with grade 3 cellulite and G2-P: 6 volunteers with grade 2 cellulite. At the end of this step, the sample for the new step will include 48 people from female, who also have the same characteristics as the previous groups. Again they will be divided equally into two groups: G1: 24 volunteers with grade 3 cellulite and G2: 24 volunteers with grade 2 cellulite. Assessment protocols, photographs, ultrasound, magnetic resonance imaging and questionnaires will be used. The treatment will take place 3 times a week for 50 minutes, and will consist of a combination of therapies such as Carboxitherapy using equipment from the Ibramed™ brand, model Aires™, phototherapy from the Ibramed™ brand, model Antares™, radiofrequency from the Ibramed® brand, the Neartek™ model and manual therapy, in addition, the volunteers will wear compressive shorts during treatment. A total of 15 sessions will be carried out and the reassessment will be carried out after the last session, with the repetition of all the exams mentioned and photos for analysis of the results.

Conditions

Cellulite

Keywords

Cellulite; Carboxytherapy; Phototherapy; Radiofrequency; Manual Therapy.

Outcome Measures

Primary Outcomes (2)

• Degree of cellulite

  Grade of skin lumpiness or skin surface dimpling often seen on the thighs, buttocks and abdomen. It is due to protrusion of subcutaneus fat into the dermis layer of skin.

  5 weeks post intervention

• Levels of sensory alterations

  Absent or reduced sensitivity to cutaneous stimulation.

  5 weeks post intervention

Secondary Outcomes (1)

• Functionality

  5 weeks post intervention

Study Arms (2)

Sanae with LED

EXPERIMENTAL

Phototherapy is related to light emission as a form of treatment for tissue and skin conditions. Its action depends on the absorption of light by chromophores, organelles present in the dermis and epidermis that give rise to cellular responses according to the different chemical reactions caused by light. The term "LED" means light emitted by a diode, thus, when the diode is subjected to an electrical current, light emission occurs (photon). Its applicability occurs in various disorders such as acne, alopecia, localized adiposity, stretch marks, cellulite, pre and postoperative, dark circles, etc. And they can also enhance treatments by promoting drainage, hydration, whitening, and rejuvenation, among other benefits.

Device: Sanae method with LED

Sanae with Radiofrecuency

PLACEBO COMPARATOR

Radiofrequency (RF) is considered a non-invasive therapy that enables thermal modification in the connective tissue of the skin, through dermal heating and vasodilation. Upon reaching the tissue, the current encounters resistance, and heat is produced by converting it into thermal energy. In this way, the deep dermis undergoes controlled volumetric heating, while the epidermis is preserved through cooling systems. Thermal damage triggers an inflammatory cascade and stimulates neocollagenesis, causing the dermis to thicken. Vasodilation, on the other hand, leads to hyperemia and lymphatic drainage in the fat tissue. The expected physiological effects are increased circulatory and nutrient supply, improving tissue hydration and oxygenation, greater metabolic and enzymatic activity, accelerating the elimination of catabolites, lipolysis, and the contraction of connective tissue.

Device: Sanae method with Radiofrecuency

Interventions

Sanae method with LED DEVICE

Sanae method (combination of therapies): Manual therapy, Carboxytherapy, and phototherapy.

Sanae with LED

Sanae method with Radiofrecuency DEVICE

Sanae method (combination of therapies): Manual therapy, Carboxytherapy, and radiofrequency.

Sanae with Radiofrecuency

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female sex
• aged between 35 and 55 years old
• multiparous or nulliparous
• using or not contraceptives
• sedentary.

You may not qualify if:

• sensitivity disorder during treatment
• do not adapt to the research times and procedures
• abnormalities in blood clotting (coagulopathy)
• use anticoagulants
• polyneuropathies
• pregnant women
• primary malignant disease (tumors) in the treatment area.

Sponsors & Collaborators

• Quiropraxia y Equilibrio: lead

Study Sites (1)

Universidade Potiguar

Natal, Lagoa Nova, 59056-000, Brazil

Location

Related Publications (8)

• Avram MM. Cellulite: a review of its physiology and treatment. J Cosmet Laser Ther. 2004 Dec;6(4):181-5. doi: 10.1080/14764170410003057.

  PMID: 16020201 RESULT

• Narins RS, Brandt F, Leyden J, Lorenc ZP, Rubin M, Smith S. A randomized, double-blind, multicenter comparison of the efficacy and tolerability of Restylane versus Zyplast for the correction of nasolabial folds. Dermatol Surg. 2003 Jun;29(6):588-95. doi: 10.1046/j.1524-4725.2003.29150.x.

  PMID: 12786700 RESULT

• Rossi AB, Vergnanini AL. Cellulite: a review. J Eur Acad Dermatol Venereol. 2000 Jul;14(4):251-62. doi: 10.1046/j.1468-3083.2000.00016.x.

  PMID: 11204512 RESULT

• Segot-Chicq E, Compan-Zaouati D, Wolkenstein P, Consoli S, Rodary C, Delvigne V, Guillou V, Poli F. Development and validation of a questionnaire to evaluate how a cosmetic product for oily skin is able to improve well-being in women. J Eur Acad Dermatol Venereol. 2007 Oct;21(9):1181-6. doi: 10.1111/j.1468-3083.2007.02193.x.

  PMID: 17894702 RESULT

• Young VL, DiBernardo BE. Comparison of Cellulite Severity Scales and Imaging Methods. Aesthet Surg J. 2021 May 18;41(6):NP521-NP537. doi: 10.1093/asj/sjaa226.

  PMID: 32785706 RESULT

• Zelickson BD, Kist D, Bernstein E, Brown DB, Ksenzenko S, Burns J, Kilmer S, Mehregan D, Pope K. Histological and ultrastructural evaluation of the effects of a radiofrequency-based nonablative dermal remodeling device: a pilot study. Arch Dermatol. 2004 Feb;140(2):204-9. doi: 10.1001/archderm.140.2.204.

  PMID: 14967794 RESULT

• Atiyeh BS, Dibo SA. Nonsurgical nonablative treatment of aging skin: radiofrequency technologies between aggressive marketing and evidence-based efficacy. Aesthetic Plast Surg. 2009 May;33(3):283-94. doi: 10.1007/s00266-009-9361-9. Epub 2009 May 13.

  PMID: 19437070 RESULT

• Barolet D. Light-emitting diodes (LEDs) in dermatology. Semin Cutan Med Surg. 2008 Dec;27(4):227-38. doi: 10.1016/j.sder.2008.08.003.

  PMID: 19150294 RESULT

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 11, 2022
• First Posted: July 1, 2022
• Study Start: September 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)