clinical study of a cosmetic cream to reduce dark circles under the eyes

1
P1050 Non-atopic dermatitis use of protopic Aditya Gupta, MD, PhD, Mediprobe Research Inc, London, ON, Canada Tacrolimus ointment (0.03% and 0.1%) is indicated for short- or long-term intermit- tent treatment of moderate to severe atopic dermatitis; however, there are also numerous non-atopic dermatitis uses for which tacrolimus has been effective. A search of the medical literature was performed to determine other uses of topical tacrolimus. Most available data come from case reports and small pilot studies rather than randomized clinical trials. A pilot study of 8 patients with vitiligo showed greater improvement during phototherapeutic therapy if treatment was combined with topical tacrolimus. Several recent cases of the photoinduced skin disorder actinic dermatitis, including the severe reticuloid form, responded successfully to tacrolimus treatment. Efficacy in prurigo was demonstrated in a recent case, with improvement occurring within one week of tacrolimus use, and remission remained over nine months posttreatment. Topical tacrolimus, through case and animal studies, has also been suggested for the treatment of alopecia areata, lichen planus, steroid-induced rosacea, lupus erythematosus, and the prevention of graft rejection. Several studies have shown tacrolimus ointment to be effective in the treatment of psoriasis, including pustular psoriasis and acrodermatitis continua suppurativa Hallopeau. Each study involving tacrolimus resulted in a good remission rate and limited adverse events such as pruritis and burning. The use of tacrolimus in atopic dermatitis has already been considered as an important alternative to topical steroids, which exert more severe adverse events with prolonged use. Future studies are required to confirm the efficacy of tacrolimus in non-atopic dermatitis skin conditions and to develop successful formulations and treatment regimens. Partially sponsored by Astellas Canada. P1051 Clinical study of a cosmetic cream to reduce dark circles under the eyes Valeria Campos, MD, Clı ´nica Vale ´ria Campos, Jundiaı ´-SP, Brazil; Rita Pompei, Futura Biotech, Campinas, Brazil; Christiana Ferreira, MD, Clı ´nica Claris, Vinhedo-SP, Brazil Objective: This clinical inquiry was lead to determine the effectiveness in the reduction of dark circles under the eyes, followed or not of swells, of a cream that contains acid kojic, extract of Morus alba, alpha bisabolol, oil of Calendula officinalis and Carapa guianensis, vitamins, and oil of grape seed, in female patients. Method: A study with 14 volunteers was carried through, with age between 22 and 62 years, that had applied the cream 2 times a day for 6 months. They had been photographed before and after the treatment and answered to a questionnaire to the ending of the evaluation. A panel was trained to evaluate the photos and to give notes from 0 to 4 to the results, being 0 equivalent to any improvement, 1 to medium reduction of dark circles, 2 to a good, 3 to a very good and 4 to an excellent result in attenuating the problem. Results: The photographic evaluation showed that the patients had a significant improvement of the problem and the percentage of answers ‘‘very good’’ and ‘‘excellent’’ was of 64%. In patient up to 34 years, this percentage went up for 80%. The questionnaire showed that 71.4% of the patients had felt improvement and 64% had felt that the cream also nourished and softened the skin. Conclusion: The cream has a good reducing action of dark circles under the eyes, mainly in younger patients. The processing fee ($ 75) is sponsored by Futura Biotech. P1052 Evaluation of the efficacy and tolerance of serum RV3718A in skin aging Michael Gold, MD, Tennessee Clinical Research Center, Nashville, TN, United States; Marie-Dominique Thouvenin, MD, Pierre Fabre Research Institute, Ramonville Saint Agne, France; Vale ´rie Mengeaud, Pierre Fabre Research Institute, Ramonville Saint Agne, France; Julie Biron, Tennessee Clinical Research Center, Nashville, TN, United States The purpose of this clinical trial, a multi-center, phase III investigation, is to evaluate the efficacy and tolerability of RV3718A in skin aging. The RV3718A serum to be evaluated contains the active ingredient delta tocopheryl glucoside 0.1%, which is an antioxidant. The delta tocopheryl glucoside (DTG) is a superior anti-oxidant properties to vitamin E. DTG as the precursor reacts with a skin enzyme to release free delta tocopheryl. Delta tocopheryl is the superior anti-oxidant form within the E family but in its natural form deteriorates rapidly when exposed to UV radiation. Delta tocopheryl is also rated by the merck index as the most effective of the E anti- oxidant family. In vitro studies suggest its use as a preventative and curative anti- aging ingredient. No clinical investigation has studied the clinical anti-aging efficacy of this ingredient. This study, a multi centered split face double-blind randomized clinical trial, on women presenting with signs of mild to moderate with skin aging, will evaluate the efficacy of delta tocopheryl glucoside on the clinical signs of skin aging. The 40 patients enrolled in this clinical trial will apply the study medication twice daily per day to half of their face for three months and then utilize the medication twice daily for an additional three months on the entire face. This is an in- use clinical trial at the time of this writing. Patients are evaluated at regular time intervals with digital photography and Visia photography to evaluate changes in the wrinkle severity scores, as well as clinical evaluations for skin roughness, skin hydration, skin elasticity, and of the smoothing effect of the RV3718A. The tolerance and cosmetic acceptability of the product is also being evaluated. RV3718A is a new antioxidant skin care serum which has shown its usefulness in the treatment of skin aging. Commercial support: None identified. DIGITAL/ELECTRONIC TECHNOLOGY P1100 Combination of reflected confocal and multiphoton microscopy for skin imaging Sung-Jan Lin, MD, PhD, National Taiwan University Hospital and College of Medicine, Taipei, Taiwan; Chen-Yuan Dong, PhD, Department of Physics, National Taiwan University, Taipei, Taiwan; Shiou-Hwa Jee, MD, PhD, National Taiwan University Hospital and College of Medicine, Taipei, Taiwan Reflected confocal microscopy has been used as a diagnostic tool in dermatology. In recent years, multiphoton microscopy has also become an popular minimally invasive technique for biomedical imaging. In this study, we combine reflected confocal microscopy and multiphoton microscopy for skin imaging. In the epider- mis, reflected confocal signals are expected to help in delineating cell borders while multiphoton signals provide cytoplasmic morphologies. In the dermis, multiphoton signals provide the morphology of collagen and elastic fibers. When 3-dimensional images are projected, the detailed distribution of cellular component and extracel- lular matrix in skin can be obtained. Our results show that the combination of these two techniques provide complementary information for skin imaging. With further development, this technique is of great potential for in vivo clinical application. Commercial support: None identified. FEBRUARY 2007 JAM ACAD DERMATOL AB97

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Page 1: Clinical study of a cosmetic cream to reduce dark circles under the eyes

P1050Non-atopic dermatitis use of protopic

Aditya Gupta, MD, PhD, Mediprobe Research Inc, London, ON, Canada

Tacrolimus ointment (0.03% and 0.1%) is indicated for short- or long-term intermit-tent treatment of moderate to severe atopic dermatitis; however, there are alsonumerous non-atopic dermatitis uses for which tacrolimus has been effective. Asearch of the medical literature was performed to determine other uses of topicaltacrolimus. Most available data come from case reports and small pilot studies ratherthan randomized clinical trials. A pilot study of 8 patients with vitiligo showedgreater improvement during phototherapeutic therapy if treatment was combinedwith topical tacrolimus. Several recent cases of the photoinduced skin disorderactinic dermatitis, including the severe reticuloid form, responded successfully totacrolimus treatment. Efficacy in prurigo was demonstrated in a recent case, withimprovement occurring within one week of tacrolimus use, and remission remainedover nine months posttreatment. Topical tacrolimus, through case and animalstudies, has also been suggested for the treatment of alopecia areata, lichen planus,steroid-induced rosacea, lupus erythematosus, and the prevention of graft rejection.Several studies have shown tacrolimus ointment to be effective in the treatment ofpsoriasis, including pustular psoriasis and acrodermatitis continua suppurativaHallopeau. Each study involving tacrolimus resulted in a good remission rate andlimited adverse events such as pruritis and burning. The use of tacrolimus in atopicdermatitis has already been considered as an important alternative to topicalsteroids, which exert more severe adverse events with prolonged use. Future studiesare required to confirm the efficacy of tacrolimus in non-atopic dermatitis skinconditions and to develop successful formulations and treatment regimens.

Partially sponsored by Astellas Canada.

P1052Evaluation of the efficacy and tolerance of serum RV3718A in skin aging

Michael Gold, MD, Tennessee Clinical Research Center, Nashville, TN, UnitedStates; Marie-Dominique Thouvenin, MD, Pierre Fabre Research Institute,Ramonville Saint Agne, France; Valerie Mengeaud, Pierre Fabre ResearchInstitute, Ramonville Saint Agne, France; Julie Biron, Tennessee ClinicalResearch Center, Nashville, TN, United States

The purpose of this clinical trial, a multi-center, phase III investigation, is to evaluatethe efficacy and tolerability of RV3718A in skin aging. The RV3718A serum to beevaluated contains the active ingredient delta tocopheryl glucoside 0.1%, which isan antioxidant. The delta tocopheryl glucoside (DTG) is a superior anti-oxidantproperties to vitamin E. DTG as the precursor reacts with a skin enzyme to releasefree delta tocopheryl. Delta tocopheryl is the superior anti-oxidant form within the Efamily but in its natural form deteriorates rapidly when exposed to UV radiation.Delta tocopheryl is also rated by the merck index as the most effective of the E anti-oxidant family. In vitro studies suggest its use as a preventative and curative anti-aging ingredient. No clinical investigation has studied the clinical anti-aging efficacyof this ingredient. This study, a multi centered split face double-blind randomizedclinical trial, on women presenting with signs of mild to moderate with skin aging,will evaluate the efficacy of delta tocopheryl glucoside on the clinical signs of skinaging. The 40 patients enrolled in this clinical trial will apply the study medicationtwice daily per day to half of their face for three months and then utilize themedication twice daily for an additional three months on the entire face. This is an in-use clinical trial at the time of this writing. Patients are evaluated at regular timeintervals with digital photography and Visia photography to evaluate changes in thewrinkle severity scores, as well as clinical evaluations for skin roughness, skinhydration, skin elasticity, and of the smoothing effect of the RV3718A. The toleranceand cosmetic acceptability of the product is also being evaluated. RV3718A is a newantioxidant skin care serum which has shown its usefulness in the treatment of skinaging.

Commercial support: None identified.

DIGITAL/ELECTRONIC TECHNOLOGY

P1100Combination of reflected confocal and multiphoton microscopy for skinimaging

Sung-Jan Lin, MD, PhD, National Taiwan University Hospital and College ofMedicine, Taipei, Taiwan; Chen-Yuan Dong, PhD, Department of Physics,National Taiwan University, Taipei, Taiwan; Shiou-Hwa Jee, MD, PhD, NationalTaiwan University Hospital and College of Medicine, Taipei, Taiwan

Reflected confocal microscopy has been used as a diagnostic tool in dermatology.In recent years, multiphoton microscopy has also become an popular minimallyinvasive technique for biomedical imaging. In this study, we combine reflectedconfocal microscopy and multiphoton microscopy for skin imaging. In the epider-mis, reflected confocal signals are expected to help in delineating cell borders whilemultiphoton signals provide cytoplasmic morphologies. In the dermis, multiphotonsignals provide the morphology of collagen and elastic fibers. When 3-dimensionalimages are projected, the detailed distribution of cellular component and extracel-lular matrix in skin can be obtained. Our results show that the combination of thesetwo techniques provide complementary information for skin imaging. With furtherdevelopment, this technique is of great potential for in vivo clinical application.

Commercial support: None identified.

P1051Clinical study of a cosmetic cream to reduce dark circles under the eyes

Valeria Campos, MD, Clınica Valeria Campos, Jundiaı-SP, Brazil; Rita Pompei,Futura Biotech, Campinas, Brazil; Christiana Ferreira, MD, Clınica Claris,Vinhedo-SP, Brazil

Objective: This clinical inquiry was lead to determine the effectiveness in thereduction of dark circles under the eyes, followed or not of swells, of a cream thatcontains acid kojic, extract of Morus alba, alpha bisabolol, oil of Calendulaofficinalis and Carapa guianensis, vitamins, and oil of grape seed, in femalepatients.

Method: A study with 14 volunteers was carried through, with age between 22 and62 years, that had applied the cream 2 times a day for 6 months. They had beenphotographed before and after the treatment and answered to a questionnaire to theending of the evaluation. A panel was trained to evaluate the photos and to givenotes from 0 to 4 to the results, being 0 equivalent to any improvement, 1 to mediumreduction of dark circles, 2 to a good, 3 to a very good and 4 to an excellent result inattenuating the problem.

Results: The photographic evaluation showed that the patients had a significantimprovement of the problem and the percentage of answers ‘‘very good’’ and‘‘excellent’’ was of 64%. In patient up to 34 years, this percentage went up for 80%.The questionnaire showed that 71.4% of the patients had felt improvement and 64%had felt that the cream also nourished and softened the skin.

Conclusion: The cream has a good reducing action of dark circles under the eyes,mainly in younger patients.

The processing fee ($ 75) is sponsored by Futura Biotech.

FEBRUARY 2007 J AM ACAD DERMATOL AB97