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NCT04835259 Clinical Trial

Efficacy of Topical Antioxidants in Tretment of Photoaging

Photoaging Clinical Trial

Official title:
Efficacy of a Combination of Topical Antioxidants in Tretment of Photoaged Skin:A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04835259
Other study ID # Soh-Med-21-01-10
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2021
Est. completion date June 2022

Study information
Verified date April 2021
Source Sohag University
Contact esraa ismail
Phone 00201000509636
Email esraasalah123@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized controlled trial study aims at investigating the efficacy and safety of topical antioxidants in treatment of a cohort of non-elderly volunteers with photoaged skin.

Description:

•Sample size calculation: The sample size was assessed prospectively using Openepi version 3.01 to provide a 80% power to detect a 40-50% difference before and after treatment using either topical antioxidants or retinoids with a significance level of 0.05 (based on the results of a previous clinical trial). Assuming 10% dropout, 30 patients will be recruited in each treatment group. •Statistical analysis: Data will be collected and recorded on excel data sheet. Data will be tested for normality. Quantitative data will be represented as mean and standard deviation, or median and interquartile range. Qualitative data will be presented as number and percentage. The relevant statistical method will be used for comparison. P value will be considered statistically significant if it is less than 0.05

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 90
Est. completion date June 2022
Est. primary completion date April 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 50 Years
Eligibility Inclusion Criteria: - Adult volunteers < 50 years old - Clinical and dermoscopic features of photoaging. Exclusion Criteria: - Genodermatoses associated with photosensitivity. - Treatment by medications affecting skin aging (eg, topical and systemic retinoids) in the last 6 months prior to enrollment. - Any recent cosmetic procedures.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Selenium Amino Acid Chelate (Selenium ACE cream)
application of a topical agent over the whole face for 6 months

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sohag University

Outcome
Type Measure Description Time frame Safety issue
Primary change in Dermoscopy photoaging scale Dermoscopy photoaging scale (DPAS) is a reliable and valid diagnostic tool that can evaluate photoaged skin quantitatively by the help of objective criteria. It can be used to evaluate the effect of preventive and therapeutic applications for skin aging. assesed every month for 6 months
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