> CLINICAL RESULTS
> GENERALITIES:
After a single application of Atoderm Xereane, the product
- Significantly increases rate of cutaneous hydration (+54.4%)*(1) in 8H. This hydrating effect persists 24 hours after application with an increase in hydration of (+22,5%)*(1).
- Increases lipid level of 1.0 μg/cm2 at T0 versus 58.0 μg/cm2 immediately after applying the product (2). This shows the nourishing effect of the product.
After 28 days of application of Atoderm Xereane twice daily, the product:
- Demonstrates decrease of the measurement of transepidermal water loss (TEWL)(a) (-10.5%)* (3).
(a)A decrease in transdermal water loss reflects an improvement in the skin's barrier function.
> ACTION ON ITCHING
Atoderm Xereane reduces itching felt by patient. More than 85% of patients thought that Atoderm Xereane relieved itching sensation (8) and skin discomfort (8)
This is achieved through the action of Antalgicine TM, a synthetic biomimetic lipopeptide. This lipopeptide is the acetylated form of a peptide naturally present in the body: Kyotorphine. It acts on the peripheral nerves and thus favors the reduction of scratching.
> ZOOM ON CANCER PATIENTS
In patients treated with chemotherapies (+/- radiotherapy) (4)
After 28 days of application of the balm on the face and body once daily, Atoderm Xerane significantly reduced xerosis; (-50%) ** of patients were xerosis-free according to the CTCAE v5.0 classification. In 95% of cases, patients experienced an improvement in their condition. (4)
The clinical signs associated with xerosis were evaluated using the SRRC score (Scaling, Roughness, Redness, Cracks): (4)
Scaling (-76.4%)** Redness (-81.8%)**
Roughness (-76.4%)** Cracks (-81.8%)**
The intensity of pruritus and erythema was also evaluated by the oncologist on a 5-point scale. The result showed a decrease in pruritus (-90%**) and erythema (-77.8%**) after 28 days.
> ZOOM ON CHRONIC RENAL FAILURE PATIENTS
After 28 days of application of Atoderm Xereane, on the face and body once to twice daily (5), the clinical signs associated with xerosis were evaluated using the SRRC score (Scaling, Roughness, Redness, Cracks). The results showed a significant decrease in: (5):
Scaling (-91%) ** Redness (-73) %*
Roughness (-73%)** Cracks (-100%)**
> ZOOM ON DIABETIC PATIENTS
After using Atoderm Xereane for 28 days, (6) the clinical signs associated with xerosis evaluated using the SRRC score (Scaling, Roughnes, Redness, Cracks) showed a significant decrease in: (6)
Scaling (-71%)** Roughness (-61%)**
Moreover, the application of Atoderm Xereane resulted in a significant reduction of pruritus (-78%)**, pain (-65%)** and insomnia (-82%)** (6).
The dermatologists considered that Atoderm Xereane was very effective for all subjects, and that this product helps to overcome the skin discomfort associated with the patient’s illness.(4.5.6)
> TOLERANCE
Clinical cutaneous and ocular tolerance evaluated by the investigating physician can be considered very good. (7)
*p<0.05, student test, after 24 hours / ** ; p< 0.0001, test de Wilcoxon; after 28 days
> PATIENTS FEEDBACKS
More than 90% of patients thought that:
- the texture of the product was rich and creamy (4)
- the skin is moisturized and soothed (4)
- the product calms the discomfort and the irritation of the skin (5)
- the skin is quickly soothed and less reactive (5)
More than 75% of patients found that the product is easy to spread and possesses ability to penetrate.(6,7)
1.Evaluation of hydration rate of Atoderm Xereane by corneometric - 10 patients (aged 29 to 70 years old) with dry or moderately hydrated skin on the inner forearms with only one application. France. 2018
2.Evaluation of the nourishing effect of Atoderm Xereane by measuring the residual fatty film - 10 patients (aged 22 to 24 years old), with only one application (Lipid level on the skin surface (in μg/cm2). France. 2018
3.Evaluation of the effect of Atoderm Xereane on reconstruction by measuring Insensible Water Loss - 12 patients (aged 27 to 67 years old) with dry and disrupted skin on the forearms with twice application. France 2018
4.Evaluation of the efficacy and tolerance of Atoderm Xereane on renal dialysis-induced xerosis - 29 patients (aged 30 to 85 years old) after twice daily application. Poland .2019-2020
5.Evaluation of the efficacy and tolerance of Atoderm Xereane on diabetics xerosis - 40 patients (aged 28 to 69 years old) after twice daily application. Mauritius. 2020
6.Evaluation of the efficacy and tolerance of Atoderm Xereane on xerosis induced by antitumor therapy - 40 patients (aged 28 to 83 years old) after twice daily application. Georgia. 2018-2019
7. User test on Atoderm Xereane – 20 volunteers (aged 27-70 years old) with dry to very dry skin after twice daily application. France. 2018.
8.User test of Atoderm Xereane – 110 volunteers (aged 18-70) with dry to very dry skin on the face and body with twice application. France. 2018
