P3203Comparative study of the regenerating properties of two cosmetic prep-arations in comparison with a positive control and an untreated controlusing the suction bubble technique

Christine Coutanceau, PhD, Pierre Fabre Research Institute, Ramonville SaintAgne, France; Dominique Alilx PhD, Pierre Fabre Research Institute, RamonvilleSaint Agne, France; Jerome Asserin, Cosderma Laboratories, Bordeaux, France

The aim of this exploratory study was to objectify the capacity of a repair creamcontaining avoine rhealba to act on the speed and quality of re-epidermisation of theskin on small superficial aggressions (suction bubbles) with respect to a comparativeproduct, a positive control and an untreated zone. Five volunteers participated inthis exploratory study. On the same subject, the product containing avoine rhealba,the comparative product and the positive control (madecassol 1% cream) wereapplied randomly on 3 different zones, the 4th zone being considered as theuntreated control zone. The products were applied every day by the investigator onthe whole surface of the zone in order to form an even layer of around 1 mm thick,for 14 consecutive days. Assessment criteria: speed of epidermisation through aquantitative approach, quality of epidermal regeneration through clinical appreci-ation of the skin’s quality. The cream containing avoine rhealba and the comparativeproduct had an average initial re-epidermisation speed 1.5 times faster than thecontrol bubble, the madecassol had a reaction 1.7 times faster. After weighting of theinitial bubble surfaces, the number of areas repaired as opposed to the untreatedcontrol bubble for the product containing avoine rhealba was equivalent to theresult obtained with madecassol (60%) and was higher than its competitor (33%).The quality of epidermisation was evaluated subjectively by the investigator. Theclinical examination at D14, highlighted a superior result for the product containingavoine rhealba as far as the fineness of the skin was in comparison with themadecassol and the comparative product. In the experimental conditions adopted,the suction bubble technique demonstrated that the 3 products tested showedactivity superior to that of the untreated control site. Furthermore, the product

P3201Silver sulphadiazine and cerium nitrate on chronic leg ulcers

Paula Dadalti, MD, MMSc, PhD, Universidade Federal do Rio de Janeiro, Riode Janeiro, Brazil; Omar Lupi, MD, MMSc, PhD, Universidade Federal do Rio deJaneiro, Rio de Janeiro, Brazil; Eduardo Cruz, MD, MBA, Fundacao BioRio, Rio deJaneiro, Brazil

Venous stasis ulcers affect a significant portion of the population and consequentlyrepresent an impact over medical costs, lead to social and psychological disability,and compromise the work productivity. When we consider a new topical therapyfor chronic ulcers, we must think about anti-microbial action as a critical level ofbacterial colonization could be responsible for delayed wound healing. Other keypoints to keep in mind is the potential of enhancing wound repair, or even inhibitingit. Finally it could ideally play anti-inflammatory properties that could accelerate thewound repair process. The association of silver sulphadiazine and cerium nitrate isa broad spectrum anti-septic agent that also creates a physical barrier, relatedto calcium precipitation, that insulates the thermally injured collagen fromenvironmental bacterial contamination functioning as a biological dressing. Wereport here 4 cases of clinical applications of silver sulphadiazine and cerium nitrateover refractory venous stasis ulcers and postulate a hypothesis about its actionmechanisms. Considering the mechanisms of delayed healing on chronic venousstasis ulcers, we postulate that the action of cerium nitrate on reducing the levels ofTNF-a in the early period after thermal injury could also happen on chronic venousstasis ulcers. The reduction of levels of this cytokine, present on high concentra-tions on the venous stasis ulcers fluid has been correlated before with fibroblastsenescence. Our hypothesis is that the application of cerium nitrate could reducelocally the levels of TNFa and consequently improve the quality of the woundfibroblasts.

Silvestre Labs has sponsored the realization of this study.

P3202Amelogenin in hard to heal venous leg ulcers: An open regimeinvestigation

Marco Romanelli, MD, PhD, Department of Dermatology University of Pisa, Pisa,AA, Italy; Valentina Dini, MD, Department of Dermatology University of Pisa,Pisa, AA, Italy; Sabrina Barbanera, MD, Department of Dermatology University ofPisa, Pisa, AA, Italy

Introduction: Amelogenin is a novel extracellular matrix protein which has shownpotential therapeutic benefit in hard-to-heal venous leg ulcers.

Objective: The aim of this study was to assess venous ulcer reduction by comparing3 different application regimens of amelogenin protein: 3 weeks, 6 weeks, 12 weeks.

Methods: Thirty-six (36) patients with persistent ([6 months)venous leg ulcerdespite compression therapy where included in this study. Patients judged to haveinadequate compression were subject to a run-in period of 4 weeks, and if a patientwas healing more than 50% of the initial wound area, was then excluded fromfurther assessments. Amelogenin in a propylene glycol alginate carrier was appliedonce weekly at the investigation visit. Compression therapy was maintainedthroughout the 12 week investigation period. Ulcer size reduction was measuredby digital planimetry. Highly exuding wounds or with clinical signs of infection wereexcluded.

Results: Patients demographic data was reasonably evenly distributed between the 3groups. The change in ulcer area, as measured in median values and expressed aspercentage of the baseline ulcer area, was calculated for all patients. Patients whoreceived the 12-week regimen showed a larger ulcer reduction compared to patientswho received the 3 or 6 week treatment with amelogenin protein.

Conclusions: This investigation indicates that a larger ulcer size reduction isobtained after a 12-week treatment regimen with amelogenin protein whencompared to 3 and 6 weeks. This despite the fact that ulcer reduction is close to50% already after 6 weeks of treatment.

Commercial support: None identified.

containing avoine rhealba showed repair activity superior to its competitor. A morelarge-scale study is planned to confirm these results.

Commercial support: None identified.

P3204A study of microcomedone formation following repetitive cutaneousapplication of a topical trolamine and sodium alginate emulsion

Margaret Nighland, Johnson & Johnson Consumer & Personal ProductsWorldwide, Skillman, NJ, United States; Sharon Levy, MD, Johnson & JohnsonConsumer & Personal Products Worldwide, Skillman, NJ, United States

Introduction: A topical emulsion of trolamine and sodium alginate promotes healingof damaged skin via recruitment of macrophages (1) and is commonly prescribed forthe treatment of wounded facial skin, including symptomatic sunburn, or afterelective facial procedures.

Objective: This study was conducted to determine the potential of repeated topicalapplications of trolamine and sodium alginate emulsion to induce microcomedones.

Methods: A trolamine and sodium alginate emulsion was applied to the upper backsof 15 healthy volunteers, 18 to 45 years-of-age, under occlusive patches 12 times, at48- to 72-hour intervals. Undosed occlusive patches applied to separate sites servedas a negative control. Test-site assignment was randomized on a site-rotational basis.Patch sites were graded for irritation using the North American contact dermatitisgroup rating scale. Follicular biopsies were taken at the conclusion of the studyto examine the size and number of microcomedones present at each site.Microcomedone formation was graded using a 5-point global assessment scale;a score of 1 or greater was considered positive for comedogenicity.

Results: Fourteen subjects (13 female and 1 male) completed the study. A follicularbiopsy was not performed for 1 subject due to overall irritation at the site oftrolamine and sodium alginate occlusion. The mean comedogenicity score was 0.65for the trolamine and sodium alginate emulsion and 0.79 for the negative control.The difference between the mean comedogenicity scores for the trolamine andsodium alginate emulsion and the negative control was not statistically significant(P # 0.05).

Conclusions: A trolamine-containing topical emulsion can be used in the treatmentof wounded skin without clinical concern of comedogenicity.

Reference:1. Coulomb B, Friteau L, Dubertret L. Biafine applied on human epidermal wounds ischemotactic for macrophages and increases the IL-1/IL-6 ratio. Skin Pharmacol1997;10:281-7.

100% sponsored by Johnson & Johnson Consumer & Personal ProductsWorldwide.

AB208 J AM ACAD DERMATOL FEBRUARY 2007