Premium
Prospective randomized clinical study of a new topical formulation for face wrinkle reduction and dermal regeneration
Author(s) -
Araco Antonino,
Francesco Araco
Publication year - 2021
Publication title -
journal of cosmetic dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.626
H-Index - 44
eISSN - 1473-2165
pISSN - 1473-2130
DOI - 10.1111/jocd.13937
Subject(s) - wrinkle , medicine , patient satisfaction , botulinum toxin , prospective cohort study , placebo , randomized controlled trial , surgery , dermatology , gerontology , alternative medicine , pathology
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.