Clinical Studies

Treatment of Cutaneous Flaccidity with * a new Natural Organic Silicon based Formulation



The cutaneous flaccidity is manifested in different areas of the skin of the body being a result of various factors of organic or external nature, for example: intrinsic skin aging, situations of sudden weight loss, nutritional deficiencies, continued exposure to sunlight, dehydration of the skin, and of course to the chronological age of the patient.

Normally, the collagen and elastin form a mesh that holds the epidermis and promotes an integral structure holding together with each other, the epidermis and subcutaneous fatty tissue.

Since this is a problem closely linked to skin aging, different histological changes that appear in older skin are visible: decreased number of fibroblasts, thinner epidermis, thickened collagen fibers, lack of ground substance and elastic fibers, etc. These morphological changes are the result of profound physiological changes that manifest themselves first at the level of the mitochondria, where they hold most of the cellular respiratory processes. Mitochondrial DNA damage, caused mainly by ultraviolet light energy, causes a failure in the repair mechanisms of oxidative damages. In the short term there is a decrease of cell metabolism and skin, thus decreasing the synthesis and excretion of collagen fibers and elastin as well as the mucopolysaccharides of ground substance. The number of fibroblasts decreases, and the dermis, the recipient of these materials, is impoverished and loses its ability of physiological rechanges.

The elasticity and skin firmness decrease give the impression it left over and hangs up, demonstrating a true flaccidity. Neck, forearms, breasts, abdomen, groin, buttocks, etc. are the areas of the body most commonly affected which manifest the symptoms described.

*EXTRAFIRM® (Concentrate Firming Gel)

A group of 25 patients with skin flaccidity had been treated in various parts of the body with a new formula that combines a Natural Organic Silicon Complex, vitamins A, E, C, sunscreen and a moisturizer complex in gelled base. A progressive improvement was found in the state of the skin, reduced flaccidity, increasing elasticity and firmness in the course of the 3-month study period.

Improve firmness, elasticity, shrinkage, moisture and condition of skin flaccidity present, confirming the beneficial effect of the new formulation *

*EXTRAFIRM® (Concentrate Firming Gel)


* We used a gel containing a Natural Organic Silicon Complex (Complex Firmness), vitamins A, E, and C, a sunscreen, and a moisturizing complex, in a gelled base

Concentrate Firming Gel * (* EXTRAFIRM ®)

Natural Organic Silicon Complex
(Firmness Complex)……………………………………………….. 6 %
Vitamins A, E and C…………………………………………………. 4 %
Sorbitol, Glycerin, Propylene glycol, MFN ………………………………………………….. 10 %
2 Ethilexil salicylate, Ti dioxide micro. ………………………… 5 %
Gelled Base………………………………………………. 100 %

The addition of the Natural Organic Silicon Complex (Firmness Complex) is a course of action that aims to standardize the tissue. The stabilizing role that develops is very important, since their presence facilitates better interaction between the fibrous proteins and glycosaminoglycans, protecting the functionality of the dermal extracellular components. It also exercises the role of bridge between the macromolecules, promoting firmness and normality to the tissue.

The activity of Vitamin A on the epidermis tends to normalize dry skin, to recover some of the normal rhythm of mitosis (cell renewal) and moderately enhancing some enzyme activities, thereby offsetting in part the changes and lacks of aging skin. Vitamin C, meanwhile, plays an important role in the synthesis of collagen and its antioxidant function is enhanced by the addition of Vitamin E, high antioxidant, moisturizer and protector over the degenerative damages suffered by the connective tissue (elastosis and loss of function of the collagen fibers). Sorbitol, glycerin and propylene glycol together with the MFN (Natural Moisture Factor) are the molecules necessary to facilitate the retention of water by the epidermal corneocytes, which allows the stratum corneum retain its functionality and flexibility. Finally the addition of 2 Ethilexil salicylate and micronized Titanium Dioxide exercise a protective power against solar radiation.

It was suggested applying the gel twice a day, for 90 days as follows:

1. Cleaning the area to be treated with a sponge soaked in soapy water.
2. Dry thoroughly.
3. Apply the gel* in a circular motion until completely absorbed.


We evaluated the biomechanical properties of skin, measuring extensibility and elasticity “in vivo” and measuring the deformation that causes a constant vertical suction, and the time needed for the deformed skin(“extension-contraction” time) to return to normal . The skin areas subject to study were settled and a force of suction was applied (suction pressure equal to 14grs.) for a preset time period (5seg.). Values obtained were taken before, during and after treatment, which lasted for 90 days.

For the evaluation were taken as a guide the following parameters:

Grade 1: Slightly flaccid skin (“extension-contraction” time 1.30 sec.)

Grade 2: Moderately flaccid skin (“extension-contraction” time 1.50 sec.)

Grade 3: Very flaccid skin (“extension-contraction” time 1.90 sec.)

The different types and locations of flaccidity that the patients presented before the application of the formula were evaluated by the parameters described before:

• 7 patients (35 to 40 years of age) had flaccidity Grade 2 on the inner surface of the thighs.

• 5 patients (40 to 50 years of age) had flaccidity Grade 2 on the inner surface of forearms and breasts.

• 4 patients (40 to 50 years of age) had flaccidity Grade 2 on breasts and buttocks area.

• 9 patients (40 to 50 years of age) had flaccidity Grade 3 on the inner surface of thighs, upper arms and breasts.

We proceeded to the application and monthly checks were carried out at 30, 60 and 90 days by checking the “Extension-Contraction Time,” as well as the firmness (semiologic manual examination) and moisture (measured in values ROV.), checking the degree of therapeutic efficacy of the new formulation of skin firming. Treated patients showed a significant improvement from the first month of treatment.

Tolerance was good in all cases, with no signs of allergy or irritation at the application site.


They are expressed in the following charts:
1. Time of Extension-Contraction


Flaccidez Grado 2

Flaccidity Grade 2

Flaccidez Grado 3

Flaccidity Grade 3


2. Skin Moisture.


From the evaluation and analysis of data it can be inferred that patients using the new formulation responded satisfactorily to the treatment, reducing flaccidity significantly and increasing the moisture and firmness of the skin. This was demonstrated by the semiologic manual examination, the measurement of moisture resulting during and in the end of treatment and the most important observation: the decrease of “Extension-Contraction” time observed during and after treatment, indicating without any doubt, the improvements made in the elasticity of the skin.

There were no pictures of allergy or adverse reactions in any of the patients treated. Some of them began treatment in the summer, so the addition of sunscreen allowed them to continue to apply the formula without any problem.

We analyzed the benefits accruing from the implementation of the new formulation * EXTRAFIRM ANTIFLACCIDEZ ® for the treatment of flaccidity.
The stabilizing action of the organic silicon complex (considered a trace element, essential component of the formula) in the connective tissue played an important role, since their presence facilitated a better interaction between the fibrous proteins and glycosaminoglycans, thus achieving protecting the extracellular dermal component functionality and also served the role of bridge between the macromolecules, promoting firmness and normality to the tissue. The addition of vitamins A, C and E, gave the formula nutritional characteristics and the addition of a sunscreen helped the skin defending from the actinic radiation.

It achieved the objective.
The decrease in flaccidity confirms the action of the new formulation *. The systematic and constant application showed the changes that were taking place, thus fulfilling the expectations, therefore we are able to say that we are dealing with a valid and effective therapeutic alternative for treating this kind of aesthetic problem of the skin.