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2008

Poster


Atopic Dermatitis

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New therapeutic anti-inflammatory action of an emollient vs topical steroids in Atopic Dermatitis

P. Msika (1), C. De Belilovsky (2), F Menu (1), C Baudouin (1), B. Chadoutaud (3).


(1) R&D Centre, Laboratoires EXPANSCIENCE, EPERNON, France, 28230.

(2) Dermatologist, PARIS, France

(3) CLINREAL ON LINE, TOULOUSE, France


Poster Abstracts American Academy of Dermatology, 66th Annual Meeting, February 1–5, 2008, San Antonio, Texas

Hypersensitive skin in children : A specific hygiene program



Clarence de Belilovsky, MD, Institut Alfred Fournier, Paris, France ; Bernard Chadoutaud, ClinReal Online, Toulouse, France ; Philippe Msika, Laboratoires Expanscience, Epernon, France

Introduction :

Sensitive skin is becoming a prominent problem among adults. To our knowledge, it has never been studied in the pediatric population, and there are no specific skin care products for hypersensitive skin in children.
New hygiene products (no-rinse gel-cream for face, body, and diaper area and cleansing foam for the body and scalp) have been conditioned under a protective atmosphere, with no perfumes or preservatives. They contain lipoaminoacid, which improves ocular and cutaneous tolerance, and patented avocado sugars which help to preserve the skin by enhancing the structural organization of the epidermis as well as the antimicrobial barrier.

Materials and methods :

Two European multicenter, open-label tests involved 40 dermatologists and pediatricians in France, Spain, and Italy. During April and May 2007, they included children (maximum age, 7 yrs) with hypersensitive skin, assessed by the accompanying person (mother or father) and cutaneous problems related to their skin fragility.

After clinical examination, face and body emollients had to be used under normal conditions for 21 days and a questionnaire was sent at the end of the two studies.


Results :

Study 1 : No-rinse gel-cream (preliminary results) 67 children (58% boys, 42% girls), mean age 3.1 years, with sensitive skin, have been included. Sixty percent had dry skin, 43% irritative dermatitis, 34% progressive dermatitis (including 18% atopic dermatitis) and 12% minor skin injuries.
Study 2 : Cleansing foam (preliminary results) 103 children (49% boys, 51% girls), mean age 3 years, with sensitive skin, have been included. Ninety-three percent had dry skin, 52% irritative dermatitis, 55% progressive dermatosis (including 38% AD) and 20% minor skin injuries.
Results were as follows (study 1/2) : tolerance, 90%/94% ; adapted to sensitive skin, 85%/87% ; efficacy, 88%/97% ; delicate cleansing, 81%/93% ; and cosmetic qualities, 80%/85%.

Conclusion :

The concept of sensitive skin is applicable to children, and specific skin care products are needed. Cleansing products must respect and protect defective skin barrier and be perfectly tolerated. For the first time, a European study has demonstrated the performances of two new cleansing gels and foams dedicated to hypersensitive skin of children.


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Evaluation of a cosmetic balm to reduce nipple pain and improve nipple skin condition in breastfeeding women



Clarence de Belilovsky, MD, Institut Alfred Fournier, Paris, France ; Bernard Chadoutaud, ClinReal Online, Toulouse, France ; Philippe Msika, Laboratoires Expanscience, Epernon, France

Introduction :

Sore nipples and cracked nipples are a frequent problem during for breastfeeding women. They seem to be related to inadequate positioning and suction of the newborn. The first symptom is pain. It may be followed by erythema, fissures, and desquamation, sometimes leading to surinfection and cessation of lactation. Women seek for a quick solution to continue breastfeeding and to avoid complications (mastitis).
The present study was designed to evaluate the effectiveness of a new nursing comfort balm with soothing and dermorepairing properties. This balm has been formulated to reduce nipple pain and cracked nipples. It contains Lupeol, patented active ingredient, soya peptides, marine salts, soothing and nourishing ingredients (chlorophycea extract, candelilla wax, etc).
Unlike many other products, this balm is free of lanolin.

Materials and methods :

Fifty breastfeeding women with nipple pain or cracked nipple have been enrolled by gynecologists and midwives in an open trial. Tested balm was applied to the nipple area after each feeding.
It did not need to be rinsed off before each feeding. Women with fungal or bacterial cutaneous infections were excluded.
Following criteria were evaluated at days 0 and 7 : pain, skin irritation, dryness, edema, fissures (cotation, 0-9) and quality of life.

Results :

Included women (mean, 32.2 yrs old) were lactating for the first time in 67% of cases, 82% exclusively. Pain appeared after a mean delay of 14.7 days, with a mean number of 6.1 feedings per day, during 20.7 minutes each. Pain disappeared for 56% of the patients with a mean delay of 2.4 days (0.5-6). Superficial and deep fissures also disappeared in 58% and 69% of cases. If not, improvement was collected in 78% and no change in 22%, with no aggravations. Irritation and dryness were reduced by 78% and 92% ; fissures and edema by 81% and 92%. Quality of life improved by 51%.

Conclusion :

A new breastfeeding balm improved lactating conditions and nursing comfort for 88% of tested women (global satisfaction rate of both investigators and patients). It has a very rapid onset of action with a mean pain relief inferior to 3 days.

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Hypersensitive skin in children : Specific skin care products



Clarence de Belilovsky, MD, Institut Alfred Fournier, Paris, France ; Bernard Chadoutaud, ClinReal Online, Toulouse, France ; Philippe Msika, Laboratoires Expanscience, Epernon, France

Introduction :

Sensitive skin is becoming a prominent problem among adults. To our knowledge, it has never been studied in the pediatric population, and there are no specific skin care products for hypersensitive skin in children.
New face and body emollients have been conditioned under protective atmosphere, with no perfumes and no preservatives. They contain lipoaminoacid, which improves ocular and cutaneous tolerance, and patented avocado sugars which help to preserve the skin by enhancing the structural organization of the epidermis as well as the antimicrobial barrier.

Materials and methods :

Two European multicenter open-label tests involved 40 dermatologists and pediatricians in France, Spain, and Italy. During April and May 2007, they included children (maximum age, 7 yrs) with hypersensitive skin, assessed by the accompanying person (mother or father) and cutaneous problems related to their skin fragility. After clinical examination, face and body emollients had to be use under normal conditions for 21 days and a questionnaire was sent at the end of the 2 studies.

Results :

Study 1 : Face emollient (preliminary results), 78 children (55% boys, 45% girls), mean age, 2.8 years, with sensitive skin, have been included. Seventy-nine percent had dry skin ; 59% irritative dermatitis ; 63% progressive dermatitis (including 28% atopic dermatitis) ; and 20% minor skin injuries.
Study 2 : Body emollient (preliminary results), 73 children (53% boys, 47% girls), mean age, 3 years, with sensitive skin, have been included. Seventy-five percent had dry skin ; 42% irritative dermatitis ; 30% progressive dermatosis (including 18% AD) ; and 12% minor skin injuries.
Results were as follows (study 1/2) : tolerance, 97%/93% ; adapted to sensitive skin, 88%/75% ; efficacy, 84%/69% ; improvement of tolerance threshold, 73%/60% ; and cosmetic qualities, 94%/91%. Global satisfaction rates were 91%/84%.

Conclusion :

The concept of sensitive skin is applicable to children and specific skin care products are needed. As for adults, they must protect the skin and be perfectly tolerated. For the first time, a European study has demonstrated the performances of two new emollients dedicated to hypersensitive skin of children.

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Kerato-regulating care for infantile seborrheic dermatitis



Clarence de Belilovsky, MD, Institut Alfred Fournier, Paris, France ; Bernard Chadoutaud, ClinReal Online, Toulouse, France ; Philippe Msika, Laboratoires Expanscience, Epernon, France

Introduction :

Infantile seborrheic dermatitis (ISD) affects almost two-thirds of newborns, mostly on the scalp, and is known as cradle cap. Its physiopathology is still debated, including hyperseborrhea, proliferation ofMfurfur, and inflammation.

A kerato-regulating care has been formulated with patented active ingredients to impact all the components of IDS. It contains alpha-hydroxy acid (AHA) esters, butylavocadate with antiseborrheic properties, capryloyl-glycine complex to limit the proliferation of microorganisms (Malassezia), aloe vera, and bourrache oil with soothing and antiinflammatory properties.

This product has been tested on babies from two different European countries.

Material and methods :

The first study was conducted in Germany by 3 dermatologists and 3 gynecologists together recruiting 30 children (mean age, 22.4 mos) with light to moderate cradle cap (initial score 3.1 on a 10-step scale). The tested product was applied every evening with shampoo every morning on 30% of children and one every other night on the other 70%.

The second study took place in Spain with 33 younger babies (mean age, 5.2 mos) affected by more severe cradle cap (initial score 4 to 5) recruited by 8 pediatric nurses. Product was applied every evening.
The two studies lasted 15 days with clinical investigations at baseline (day 0) and day 15.

Results were analyzed by nonparametric Wilcoxon test for the second study.

Results :

Results are in the same range for the two studies.
Total clearance of the scales : 49% first study/52% second study (mean delay calculated for the second study, 10.4 days) ; investigator global assessment : 87%/82% (P ¼ .03 vs. day 0) efficacy ; scales severity : 81%/73% (P \.01 vs. day 0) improvement ; erythema severity : 100%/85% (P\.01 vs. day 0) improvement ; pruritus : 80%/83% (P\.01 vs. day 0) decrease. Parents’ assessments were similar : 63%/75% for the scales elimination.
Cosmetics properties were the following : light texture : 97%/97% ; easy cleansing : 97%/97% ; nonirritating : 93%/97%.

Conclusion :

A patented cosmetic product has proven its efficacy for infantile seborrheic dermatitis in two European studies. It is recommended as a first line care for cradle cap, 7 or 3.5 days a week and acts rapidly (mean, 10.4 days total clearance).

A new and innovative emollient with Cu-Zn-Mn triad for irritant and allergic dermatitis



Dalale Naaimi, Laboratoires Expanscience, Epernon, France ; Clarence de Belilovsky, Institut Alfred Fournier, Paris, France ; Caroline Baudouin, Laboratoires Expanscience, Epernon, France ; Bernard Chadoutaud, ClinReal Online, Toulouse, France

Introduction :

Irritant, allergic contact dermatitis (ICD, ACD), and atopic dermatitis (AD), beside therapeutic prescriptions, need a specific cosmetic management with emollient, antiirritant, antimicrobial, and healing products.
A new emulsion for ICD and ACD with no antiseptic, no common preservative, no perfume, and no colorant has been developed.
It contains the first oligo-element triad (Cu-Zn-Mn), phytosphingosines, a glycerol/capryl glycol complex and dimethyl oxobenzo dioxasilane. First, we investigated the in vitro effect of [Cu-Zn-Mn] triad on the skin repair improvement.
Then, the clinical efficacy and tolerance of the new emulsion have been performed.

Methods :

After treatment of fibroblasts or keratinocytes with [Cu-Zn-Mn] triad, we examined cell migration and proliferation by the scratch-assay and we evaluated the markers of keratinocytes proliferation (b1-integrin), differentiation (involucrin) and dermaleepidermal junction (b4-integrin) using ELISA. Clinical efficacy of the emulsion has been tested on 139 patients with 67% of children.
They were affected by various pathologies : irritation from external origin ; AD and ACD and superficial cutaneous alterations. The tested product was applied twice daily for 10 days.

Results :

In vitro, we have shown that the [Cu-Zn-Mn] triad acted at different levels of the skin in order to enhance wound healing by promoting re-epithelialisation, reinforcing dermal-epidermal junction and improving dermal wound recovery.
Moreover, in clinical study, overall, the product was efficient on 81% of the patients and the following improvements were reported : pain 83%, irritancy 91%, discomfort 90%, pruritus 88%, erythema 88%, dryness 89%, acceleration of healing time 77%, and cicatricial aspect 78%. The comparison of the 3 groups revealed firstly that the Cu-Zn-Mn triad was efficient for all the dermatological conditions tested, and secondly that this product is totally adapted for children : irritant dermatitis (82%), eczemas (83%), and other cutaneous alterations (91%).

Conclusion :

A new Cu-Zn-Mn emollient has been developed for various irritant, allergic and traumatic dermatitis and give excellent results for adults and children. It was the first time that we could demonstrate that the Mn addition to the Cu-Zn complex stimulates the epidermal regeneration and restores skin barrier function.


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