ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy

Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 Information herein contained represent an intellectual property right of

The GENERAL TOPICS Company

Divulgation can be allowed only after written consent of the General Topics Company.

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
ACNE – AKNICARE – ENERPEEL SA General Topics srl
Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
ACNE – AKNICARE – ENERPEEL SA General Topics srl
Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 ETIOPATHOGENESIS

THE ETIOPATHOGENESIS OF ACNE INVOLVES THREE BASIC FACTORS, WHICH

TAKE THE FOLLOWING FORM:

HYPER SEBORRHEA
HYPER KERATINIZATION
BACTERIAL COLONIZATION
INFLAMMATION

AKNICARE General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 SEBORRHEA

INCREASED SEBUM PRODUCTION – SEBORRHEA

Even if not necessarily seborrhea leads to acne, it exists a direct relationship between acne
severity and increased sebum production.

Testosterone 5-α reductase Dihydrotestosterone

Androgen receptors of sebocytes

INCREASED SEBUM
PRODUCTION

AKNICARE General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
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 SEBUM COMPOSITION

AKNICARE General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
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 TRYGLICERIDES

The esters are generated from the union of an acid with an alcohol.

Free fatty acids (generated from the hydrolysis of esters) are detectable in the lipids of sebaceous origin.

Their presence is therefore attributable to hydrolysis of lipid esters including cholesterol esters, wax esters, but
mainly triglycerides (esters of glycerol).

The fatty acids generated by hydrolysis of the different lipid esters are characterized by inflammatory and
comedogenic activity.

AKNICARE General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
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Hyperplasia of sebaceous Hyper keratosis
gland TRIGLYCERIDS Formation of horny plug
Hyper seborrhea Retention

Bacterial colonization Hydrolysis of triglycerids

(Propionibacterium Acnes) by bacterial esterases
Release of Release of
proteases and esterases Inflammatory free fatty acids

Neutrophil Chemiotaxis
Fatty acids
release of ROS
oxidation
(Reactive Oxygen Species)

Formation of compounds with Micro comedo

Inflammation
pro – inflammatory activity development

ACNEIC LESION

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 STATUS ARTIS
HYPERSEBORRHEA HYPERKERATINIZATION
NONE Tretinoin
Isotretinoin
Adapalene

ACNE PATHOGENESIS FACTORS Tazarotene

Azelaic acid
Retinalaldehyd

Retinyl--glucuronide

MICROBES INFLAMMATION
Erythromycin Adapalene
Clyndamicin Azelaic acid
Tetracyclines Corticosteroid
Topical treatment in acne: current status and future aspects
Chloramphenicol Harald P.M. Gollnick Andrea Krautheim
Dermatology 2003;206:29-36
Azelaic acid
BPO
Retinoids?

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro,General
32 – San Felice
Topics del Benaco
srl – Italy
ACNE – Rev.
AKNICARE
0 - 2011
– ENERPEEL SA Phone: +39-0365-522617
Località Santigaro, 32 –email: [email protected]
San Felice del Benaco – Italy
 THE COMBINED ACTION OF

TRIETHYL CITRATE ETHYL LINOLEATE

ACTIVE ON

SEBORRHEA

BACTERIAL COLONIZATION

HYPER KERATINIZATION

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
BACTERIAL LIPASES SHOWED HIGHER AFFINITY FOR THE SUBSTRATE
REPRESENTED BY TRIETHYL CITRATE THAN TRIGLYCERIDES

BACTERIAL
LIPASES

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 INHIBITION OF THE ENZYMATIC HYDROLYSIS (LIPASES) OF
TRIGLYCERIDES INDUCED BY TRIETHYL CITRATE

Absorbance fatty acids reduction

Mean compared to control

15’ 30’ 15’ 30’

Control 0,7125 0,095 --- --

TEC 0,5% 0,584 0,084 18,04 11,10

TEC 1% 0,5905 0,083 17,12 12,70

TEC 5% 0,393 0,018 44,84 81,50

baseline 4 weeks 12 weeks

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
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 A NEW THERAPEUTIC PROTOCOL FOR
THE TREATMENT OF MILD TO MODERATE COMEDONIC AND INFLAMMATORY
ACNE

THE MEDICATED SALICYLIC ACID PEEL.

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
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THE MEDICATED SALICYLIC ACID PEEL

30%
SALICYLIC ACID

TRIETHYL CITRATE ETHYL LINOLEATE

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
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 SALICYLIC ACID OVERVIEW
COOH

OH • Salicylic acid exerts a specific

keratolytic acting on proteic
structures of the skin (keratin);
• Salicylic acid, because of its
lipophilic properties, is able to
SALICYLIC ACID detach the interlammelar lipids of
the horny layer.

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 SALICYLIC ACID OVERVIEW

BASAL Immediately after the peel

After 1 hour After 12 hour

Immediately after treatment with 30.0% salicylic acid, the cornified cell layer
showed a temporary thickening up to 2.5 times the pretreatment thickness.
The cornified layer then thinned markedly within 1 hour, and became
further attenuated up to 12 hours after treatment, showing a thickness one
half of that before treatment. The attenuation of this cornified layer was
mainly caused by a shedding of the shrunken cornified cells from the skin
surface.

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 SALICYLIC ACID OVERVIEW

At 3 hours after treatment, the epidermis appears uniformly thin due to an extensive loss of cornified cells and the
thinning of the residual epidermis.
At 12 hours after treatment, the cornified cells within the hair follicles are macerated, and then become detached
above the granular cells.
At 24 hours, the cornified cells have been shed above the granular cells, leaving the lower cells intact. No
degenerative, necrotic, acantholytic, or inflammatory changes have occurred

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 PSYCHOLOGICAL ASPECTS OF THE ACNEIC PATIENT

J Am Acad Dermatol 1988 Feb;18(2 Pt 1):325-33

As many scientific studies confirm, acne has a deep psycological and social
impact on patient’s wellness who often show embarassment and depression.

Subject who suffer of acne, show a strong decrease of self confidence.

Very often patients show feelings of shame (70% of the cases),

embarassment e anxiety (63% of the cases), to be in trouble to get through
other people ( 57% of the cases) and problems to find and to keep a job.

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 CHEMO EXFOLIATION IN THE MANAGEMENT OF ACNE

Chemo exfoliation (chemical “peeling”) is a medical procedure that

determines a controlled damage to the skin by the application of organic
acids.
This procedure is utilized to improve specific skin conditions by :
•removing dead cells from the stratum corneum,
•regenerating the vital portion of the epidermis and
•remodeling the dermis.

Peeling for acne are normally utilized to treat medium to deep post acneic
scars.

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
THE NEW THERAPEUTIC PROTOCOL FOR MILD – MODERATE COMEDONAL
AND INFLAMMATORY ACNE

OPEN MULTICENTIC STUDY TO TEST THE EFFICACY OF A NEW THERAPEUTIC

PROTOCOL OF ACNE VULGARIS

BOLOGNA Clinica Dermatologica Ospedale S. Orsola

CATANIA Clinica Dermatologica dell’Università di Catania
FERRARA Università di Ferrara
MILANO Clinica Dermatologica dell’Università di Milano
NAPOLI Università “Federico II” – Napoli
ROMA Istituto I.F.O. San Gallicano
U.O.C universitaria di dermatologia

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 GOAL OF THE STUDY

Evaluation of the efficacy and tolerability of the therapeutic protocol based

on the combined use of the Chemo exfoliating device based on 30% salicylic
acid, triethylcitrate and ethyl linoleate characterized by a particular
technology* and medical devices based on triethylcitrate and ethyl linoleate
in comedonal and inflammatory acne of the face.

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 THE NEW THERAPEUTIC PROTOCOL FOR MILD – MODERATE COMEDONAL
AND INFLAMMATORY ACNE

ASSESMENT

Every subject has been evaluated on:

T-15 Enlistment

T0 baseline - in occasion of the 1st CHEMOEXFOLIANT TREATMENT

T10 in occasion of the 2nd CHEMOEXFOLIANT TREATMENT(after 10 days)

T20 in occasion of the 3rd CHEMOEXFOLIANT TREATMENT(after 20 days)

T30 in occasion of the 4th CHEMOEXFOLIANT TREATMENT(after 30 days)

T50 the last evaluation will be done 20 days after the last session of chemo exfoliation (after 50 days
from the baseline)

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
THE NEW THERAPEUTIC PROTOCOL FOR MILD – MODERATE COMEDONAL
AND INFLAMMATORY ACNE

STUDY PROTOCOL

1. Preparation of the skin for chemo exfoliation

2. Chemo exfoliation (IN 4 SESSIONS)
3. Inter treatment btw sessions
4. Post treatment

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
THE NEW THERAPEUTIC PROTOCOL FOR MILD – MODERATE COMEDONAL
AND INFLAMMATORY ACNE

CHEMO EXFOLIATING SESSIONS WITH ENERPEEL SA

The patients have undergone 4 chemo exfoliating sessions (t0, t10, t20, t30)
with the acid solution based on SALICYLIC ACID, TRIETHYL CITRATE and
ETHYL LINOLEATE characterized by the Enerpeel Technology on the whole
surface of the face at intervals of 10 ± 2 days ( 2,5 ml for every application,
1,25 ml per layer).

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 CLASS III Medical Device

PRE - INTER – POST TREATMENT

AKNICARE Cream
TRIETHYL CITRATE – ETHYL LINOLEATE – SALICYLIC ACID (0,2%)

During the sunny season AKNICARE Sun has been applied in the morning
and AKNICARE cream in the evening.

AKNICARE Sun Cream

UV Filters (SPF 30 PPD 20) – TRIETHYL CITRATE

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 PATIENTS AND METHODS

NR. PATIENTS: 56
AGE: 14 – 37 ANNI
ETHNIC ORIGIN: Caucasian
SEVERITY OF PATHOLOGY: mild-moderate comedonal and inflammatory acne
of the face
DURATION PATHOLOGY: pre existing acne since some years
CRITERIA OF EVALUATION: clinical and photographic evaluation of the severity of acne based on
the Global Acne Grading System (GAGS)1, count of
inflammatory and non inflammatory lesions
DURATION of the STUDY: 65 Days
CONTROLS: T-15, T0, T10, T20, T30, T50,

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 RESULTS
ENERPEEL SA + AKNICARE

The results show a remarkable improvement of the clinical situation (-50%) with an improvement both of the
inflammatory and non inflammatory lesions.

The chemo exfoliant sessions in the course of the topical treatment allowed a constant and punctual
monitoring of the clinical progress and to intensify the relation of trust with the patient.

The peeling has demonstrated to be effective and well tolerated by all patients.

No side effects in terms of erythema, burning sensations, excessive desquamation, have been observed, while
they are normally present at other similar procedures.

The patients declared to be satisfied with the obtained results.

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 REDUCTION OF WHITEHEADS
T-15 T50

-64,04%

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 REDUCTION OF WHITEHEADS
T-0 T50
P<0.001

-57,15%

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 REDUCTION OF BLACKHEADS
T-15 T50

-69,52%

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 REDUCTION OF BLACKHEADS
T0 - T50
P<0.001

-61,18%

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 REDUCTION OF PAPULES
T-15 T50

-69,62%

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 REDUCTION OF PAPULES
T0 - T50

-60,88%

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 REDUCTION OF PUSTULES
T15 - T50

-85,16%

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 REDUCTION OF PUSTULES
T0 - T50

-82,33%

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 GLOBAL SCORE
T-15 - T50

GLOBAL SCORE

25,00

20,33
20,00

15,00

-49,09%
10,35
10,00

5,00

0,00
t-15 t50

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
 GLOBAL SCORE
T0 - T50

-45,51%

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
ACNE – AKNICARE – ENERPEEL SA General Topics srl
Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
ACNE – AKNICARE – ENERPEEL SA General Topics srl
Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
ACNE – AKNICARE – ENERPEEL SA General Topics srl
Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
ACNE – AKNICARE – ENERPEEL SA General Topics srl
Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
ACNE – AKNICARE – ENERPEEL SA General Topics srl
Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
ACNE – AKNICARE – ENERPEEL SA General Topics srl
Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
ACNE – AKNICARE – ENERPEEL SA General Topics srl
Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]
INTRINSIC ADVANTAGES

EFFECTIVE
SAFE
EASY TO HANDLE
SHORT TIME PROCEDURE
CUSTOMIZABLE
ACNE – AKNICARE – ENERPEEL SA General Topics srl
Località Santigaro, 32 – San Felice del Benaco – Italy
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 PATIENT BENEFITS

A better relationship with a very special patient: The adolescent

It improves the compliance of the patient

The great tolerability allows the highest adherence to the inter treatment
Visible results in a shorter time: the doctor gains the fidelity of the patient
for his/her entire life

ACNE – AKNICARE – ENERPEEL SA General Topics srl

Località Santigaro, 32 – San Felice del Benaco – Italy
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ACNE – AKNICARE – ENERPEEL SA General Topics srl
Località Santigaro, 32 – San Felice del Benaco – Italy
Rev. 0 - 2011 Phone: +39-0365-522617 email: [email protected]