Philippe Msika, Laboratoires Expanscience, Epernon, France ; Bernard
Chadoutaud, Clinreal Online, Toulouse, France ; Caroline Baudouin, Laboratoires
Expanscience, Epernon, France ; Clarence de Belilovsky, Institut Alfred Fournier,
Atopic dermatitis (AD) is a chronic dermatosis requiring permanent skin care. This goal can be achieved by emollients, often in conjunction with topical steroids if needed. In a previous study, an emollient containing a natural patented active ingredient (2% sunflower oleodistillate [SOD]) has demonstrated a 75% corticosteroid sparing effect (steroid class II, desonide 0.05%). In this new European multicenter study, its applications have been compared to those of a more potent steroid (class III, hydrocortisone aceponate cream 1.27mg/g).
During an open comparative study, two groups of 40 children with light to moderate AD have been included by 12 dermatologists. All children received soapfree washing oil. Group A applied the steroid two times a day on affected areas and group B the emollient on lesions and on the entire body two times a day. Children were examined, and Scoring Atopic Dermatitis (SCORAD) scores were established at days 0, 7, and 21. Quality of life questionnaires were filled at days 7 and 21. Results : The mean age of the children was 2.3 and 2.4 years in groups A and B. At day 0, SCORAD was similar in the two groups : 37.2 versus 36.9 (moderate AD). In both groups, improvements were statistically significant versus DO at day 7 (-49% and -48%) and day 21 (-70% and -75%). There were no statistic differences between SCORAD at day 21 (11 vs 9.4). All items of SCORAD improved in the same range except for xerosis which was naturally better improved by the emollient (-81%) than in the steroid group at D21 (-53% ; P\.01). This latter result in the steroid group might be attributed to the soap-free washing oil. Investigator assessment stated that the emollient could reduce the frequency of atopic flares (93%) and the intensity of flares (90%), with no statistic difference between the two groups at day 21. Infant Dermatitis Quality Of Life (IDQOL) improved by 65% with the steroid and 72% with the emollient at day 21 (P\.01 vs D0 and no significant difference between two groups). Similarly, the Dermatitis Family Impact Questionnaire (DFIQ) score was reduced by 67% and 75% (idem).
For the first time, a cosmetic emollient containing 2% patented SOD has demonstrated therapeutic properties comparable to those of a class III steroid in a 3-week comparative study. The impact on the quality of life tended to be better but did not reach a significant difference. These properties of the tested emollient on AD might rely on its natural agonist PPAR-alfa properties, previously demonstrated in vitro.
Philippe Msika, MD, Laboratoires Expancience, Epernon, France ; Bernard
Chadoutaud, Clinreal Online, Toulouse, France ; Caroline Baudouin,
Laboratoires Expanscience, Epernon, France ; Clarence de Belilovsky, Institut
Alfred Fournier, Paris, France ; Franck Menu, Laboratoires Expanscience,
During atopic dermatitis (AD), all washing products must preserve the mechanical and biologic skin barrier function, soothe the skin, and even improve other skin cares. For that purpose, a cosmetic baby product hygiene line dedicated to atopic skin has been developed. All three products are perfume and paraben free. They all contain mild vegetal surfactants and sunflower oleodistillate (SOD), a patented molecule which stimulates lipogenesis via agonist PPAR-alfa properties.
Each product has been tested, in open studies, on 100 children, aged[3 months, with light to moderate AD, by dermatologists, pediatricians, and pediatric nurses, during 3 weeks, in France and Spain. Other skin cares (emollients and steroids) were not changed and used as needed. Clinical examination (dryness, erythema, desquamation, and pruritus) and the quality of life assessments Infant Dermatitis Quality of Life (IDQOL) and Dermatitis Family Impact Questionnaire (DFIQ) were performed at days 0 and 21. Study A used a no-rinse cleansing water, used on the face, the body, or the nappy area as needed. Study B used a cleansing cream for hair and body, and study C used a milky bath oil, used either during shower or bath without rinsing.
Most of the children (3.6-5.3 yrs old) were included during a flare of AD (study A, 85% ; B, 74% ; C, 88%) and applied hygiene products on lesional skin (88%/95%/99%). Sisxty-six percent/89%/84% continued their usual emollient during the study period and 19%/48%/38% continued with their topical steroid (7%/14%/11% compared to 1 month earlier). In all three studies, all clinical and quality of life scores improved by at least 50% (P\.01) by day 21. For clinical scores, a comparison between children receiving solely hygiene products and combined to emollient and/or steroid showed no difference. Investigator assessments : The products are adapted to AD hygiene (study A, 95% ; B, 99% ; C, 86%) and decrease a given AD flare’s intensity (77%/77%/76%) and frequency (63%/74%/64%). For the parents, these products clean the skin softly (98%/100%/91%), especially on lesional skin (82%/98%/83%). They are nonirritating (98%/100%/99%), soothing (80%/88%/83%), hydrating (83%/84%/80%), and the child reacts favorably after application (92%/99%/94%).
During ‘‘use-test conditions’’ studies, three specific AD hygiene products containing active patented ingredient (SOD), applied alone or associated to regular cosmetic skin cares and therapies, have demonstrated a >50% improvement both for clinical signs and of quality of life.