An Open Label, Non Comparative, Non-randomized, Pilot study to see the efficacy and safety of anti wrinkle cream in the treatment of facial skin wrinkles

Background: Wrinkles are the clinical manifestation of ‘coetaneous aging’ and factors associated with wrinkles could be ‘intrinsic’ and ‘extrinsic’. The “Anti-Wrinkle cream” is a poly-herbal formulation recommended for the management of skin wrinkling. Aims and objectives: This study was planned to evaluate the efficacy and safety of the “Anti-Wrinkle cream” in the management of facial skin wrinkles. Material and methods: After confirming eligibility, 30 patients were enrolled in the study and each of the patients was provided with Anti-Wrinkle cream. The regimen of Anti-Wrinkle cream was followed in each of the patient for study duration of 06 weeks.This was conducted in accordance to the ICH-GCP guidelines with approval from Independent Ethics Committee. Written Informed consent was obtained from these patients after a thorough explanation of the study.Patients with wrinkles on the face and neck were included in the study. These patients agreed to restrain from prolonged exposure to the sun for the length of the study. Results and discussion: The patients were assessed for Modified Fitzpatrick Wrinkle Scale (MFWS), improvement in ‘Quality of Life’, ‘Patient Satisfaction Questionnaire’, Physician's and Patient Global Assessment Grade for improvement in wrinkles and Photographic assessment at baseline, 3 weeks and 6 weeks.The average MFWS (Modified Fitzpatrick Wrinkle Scale) at baseline (Visit 1) was 2.1 which was reduced to 1.6 after 3 weeks of treatment (Visit 2) and further reduced to 1.2 after 6 weeks of treatment (Visit 3) with Anti-Wrinkle cream.The Physician’s and Patient’s global assessment also showed improvement in wrinkles at visit 2 and visit 3. Conclusion: In our study it was noted that, Anti-Wrinkle cream appears to be effective and safer alternative with 6 weeks of therapy. In terms of efficacy, there was a moderate to significant reduction in the MFWS score for the treatment groups, brought about with 6 weeks of treatment. Limitations and recommendation: This was a pilot study conducted only on 50 subjects with only single study centre furthermore comprehensive and detailed multi centric study can be done to evaluate the effectiveness of “Anti-Wrinkle cream”.