Evaluation of the efficacy and safety of “Anti-Wrinkle cream” in the treatment of facial skin wrinkles: A prospective, open, phase III clinical trial

Aging of the skin is the result of continuous "wear and tear" processes. Chronological skin aging is a universal and inevitable process, while in contrast, photoaging results from the UV rays of sunlight, and the damage becomes apparent in sun-exposed skin. The “AntiWrinkle cream” is a polyherbal formulation recommended for the management of skin wrink the efficacy and safety of the “Anti-Wrinkle wrinkles. This study was a prospective, open, phase III guidelines of Declaration of Helsinki. A total of 2 years, with wrinkled facial skin, and who we included in the study. Persons with known hype formulation, any facial wound or abrasion, and w were excluded from the study. A baseline hist patient’s eligibility for enrolment in the trial. All Wrinkle cream”, twice-a-day for a period of 6 we was done by a predefined global grading system “No improvement”, “fair improvement”, “ improvement” and “excellent improvement”. All 6 weeks, and at each weekly follow-up visit, the wrinkling was evaluated. At the end of the 6 w Wrinkle cream” was evaluated. The predefined wrinkles, and the predefined secondary safety assessed by incidence of adverse events, and adverse events reported or observed by the patien severity, date of onset, duration and action taken was done according to intent-to-treat principles. This study observed a significant improvement application in almost all persons and also, th reactions, with excellent overall compliance. This synergistic antioxidant, anti-inflammatory, and U which also have excellent safety profile. Therefo cream” is effective and safe for usage in the mana 1 ABBREVIATIONS DNA : Deoxyribonucleic acid LPS : Lipopolysaccharide NO : Nitric oxide PAF : Plasminogen activating factor ROS : Reactive oxygen species UVR : Ultraviolet rays ling and this study was planned to evaluate cream” in the management of facial skin clinical trial, conducted as per the ethical 5 patients, of both sexes, aged from 35 to 65 re willing to give informed consent were rsensitivity to any of the ingredients of the ho were not willing to give informed consent ory was obtained in order to determine the the patients were advised to apply the “Antieks. The subjective improvement evaluation , which included the following gradations: remarkable improvement”, “very good the patients were followed up for a period of dermal safety and the improvement in skin eek, the overall performance of the “Antiprimary end point was reduction in skin endpoints (for shortand long-term) were patient compliance to the therapy. All the ts were recorded with information about the regarding the study drug. Statistical analysis in the facial skin wrinkles, after a week’s ere were no clinically significant adverse beneficial effect might have been due to the VR protective properties of the ingredients, re, it may be concluded that “Anti-Wrinkle gement of facial skin wrinkles. INTRODUCTION Aging of the skin is the result of continuous "wear and tear" processes, which damage cellular DNA and proteins. Aging has been classified into 2 distinct types, viz. “chronological skin aging” and “photoaging” and both types have distinct clinical and histological features. Chronological skin aging is a universal and inevitable process, characterized primarily by physiologic alterations in skin function. In chronological skin aging, keratinocytes are terminally unable to form a functional stratum corneum, and the rate of formation of neutral lipids (which contribute to the barrier functions) gets slowed, resulting in dry, pale skin with fine wrinkles. In contrast, photoaging results from the UV rays of sunlight, and the damage becomes apparent in sun-exposed skin. Characteristics of photoaging are dry and sallow skin, displaying fine wrinkles as well as deep furrows, resulting from the disorganization of epidermal and dermal components associated with elastosis and heliodermatitis. The “Anti-Wrinkle cream” is a polyherbal formulation recommended for the management of skin wrinkling, and it contains the extracts of Aloe vera, Papaver rhoeas, Vitis vinifera, Citrus limon, Solanum lycopersicum, Santalum album, Rubia cordifolia, Saussurea lappa, Lens culinaris, Symplocos racemosa, Amomum subulatum, Curcuma longa, Glycyrrhiza glabra, Valeriana wallichii, Vetiveria zizanoides and oil of Triticum sativum. This study was planned to evaluate the efficacy and safety of the “Anti-Wrinkle cream” in the management of facial skin wrinkles. Aim of the study This study was planned to evaluate the clinical efficacy and safety (shortand long-term) of the “Anti-Wrinkle cream” in the management of facial skin wrinkles. MATERIALS AND METHODS Study design This study was a prospective, open, phase III clinical trial, conducted at the Department of Dermatology of Apollo Hospitals, Chennai, India, as per the ethical guidelines of Declaration of Helsinki, from June to September 2004. The study protocol, case report forms, regulatory clearance documents, product related information and informed consent form (in Tamil and English) were submitted to the “Institutional Ethics Committee” and were approved by the same. Inclusion criteria A total of 25 patients, of both sexes, aged from 35 to 65 years, with wrinkled facial skin, and who were willing to give informed consent were included in the study. Exclusion criteria Persons with known hypersensitivity to any of the ingredients of the formulation, any facial wound or abrasion, and who were not willing to give informed consent were excluded from the study. Study procedure A baseline history was obtained in order to determine the patient’s eligibility for enrolment in the trial. The baseline assessment included personal data, a description of symptoms and details of past medical history (family history, history of possible exacerbating factor/s, etc.). All the patients were advised to apply the “Anti-Wrinkle cream”, twice-a-day for a period of 6 weeks. The subjective improvement evaluation was done by a predefined global grading