Prospective randomized clinical study of a new topical formulation for face wrinkle reduction and dermal regeneration.

[BACKGROUND] A new topical formulation (TF) based on 3 main lifting components has been developed to reduce superficial facial wrinkles.

[OBJECTIVES] Determine the effectiveness of this new TF in reducing superficial face wrinkles and restructuring the dermal matrix.

[METHODS] Women, aged 30-65 y.o. with moderate to severe crow's feet wrinkles were included.

[EXCLUSION CRITERIA] men; younger than 30 or older than 65 years old; smokers. Patients received 15 IU of botulinum toxin on crow's feet and 2 creams. Fifty patients (Group 1) applied the TP (Product A) and 50 (Group 2) a placebo (Product B). Assessments were made by digital macro-photography's, Antera 3D, and a patient satisfaction questionnaire.

[RESULTS] From April to June 2019, 100 women were enrolled in the study and were divided into two homogeneous groups. No major or minor side effects were reported. In group 1, wrinkles, texture, static and dynamic crow's feet wrinkles improved significantly at 3 and 6 months. Patients were very satisfied at 3 months and satisfied at 6 months. In group 2, wrinkles and texture improved significantly at 3 months but did not improve at 6 months. Static and dynamic crow's feet wrinkles improved significantly at 1 and 3 months but did not improve significantly at 6 months.

[CONCLUSIONS] Our prospective and randomized study has shown that the new TF is safe and effective in reducing superficial face wrinkles and producing dermal regeneration. It, therefore, prolongs the duration of the botulinum toxin. Further controlled study would be necessary to compare the new TF to neurotoxin treatment, or its action alone.