RESUMO
BACKGROUND: Recently, many compounds or extracts from natural sources are used for reducing facial aging and wrinkles. OBJECTIVE: This study investigates the preparation and evaluation of the safety and efficacy of saffron extract and avocado oil used for anti-wrinkle topical cream. METHODS AND MATERIALS: Oil in water cream was prepared containing avocado oil and the saffron extract. Accelerated stability tests were carried out due to 6 months accordingly through the International Council for Harmonization (ICH) guideline. For clinical studies, topical cream was applied by twenty healthy volunteers daily, for 12 weeks. Improvement in wrinkle grading by a Global Aesthetic Improvement Scale (GIAS), depth and volume of the nasolabial fold, thickness, and density of dermis, and determination of the skin biophysical parameters were evaluated at the baseline, 6th and 12th week. RESULT: During the period of storage, the formulation showed no variation in physicochemical properties. The clinical evaluation showed at least one-grade improvement in GIAS in 30% and 45% of participants, after 6 and 12 weeks, respectively. Subjects were "moderately satisfied" with the treatment. In addition, the area and volume of nasolabial folds were significantly reduced. Moreover, net elasticity (R5) and gross elasticity (R2) showed a significant increase after 12 weeks of treatment. There was no report of allergic reactions, and no changes in skin hydration occurred during the treatment. CONCLUSION: The results of this study showed that saffron extract and avocado oil anti-wrinkle topical cream is an efficient and safe treatment for facial skin rejuvenation.