Efficacy of Topical Antioxidants in Tretment of Photoaging

Not Applicable

• Conditions: Photoaging
• Interventions: Drug: Selenium Amino Acid Chelate (Selenium ACE cream)

• Registration Number: NCT04835259
• Lead Sponsor: Sohag University

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2021-01-19
• Status Verified: 2021-04
• Study Start: 2021-04
• Study First Submitted QC: 2021-04-04
• Study First Posted: 2021-04-08
• Last Update Submitted: 2021-04-18
• Last Update Posted: 2021-04-20
• Primary Completion: 2022-04
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1(treatment group)	Selenium Amino Acid Chelate (Selenium ACE cream)	Topical application of a cream of a combination of antioxidants once daily at night for 6 months Name: Selenium ACE cream (Interpharma UK company, Egypt) Ingredients: Selenium (Selenium amino acid chelate) 0.5% Vitamin C (Sodium ascorbyl phosphate - stay C) %1 Vitamin E (Tocopheryl acetate) % 0.5 Vitamin A (Retinyl palmitate) %1 Emulsifiers ( Ceteareth 20 , Glycerol monostearate , Cetyl alcohol) Emollient(Caprylic capric triglycerides)
Group 2 (positive control)	Selenium Amino Acid Chelate (Selenium ACE cream)	Topical application of a retinoid (tretinoin 0.05%) cream once daily at night for 6 months (Acretin 0.05% cream Jamjoom pharmaceuticals, Egypt)
Group 3 (Negative control)	Selenium Amino Acid Chelate (Selenium ACE cream)	Topical application of a panthenol cream once daily at night for 6 months (panthenol 2% cream, El Nile company, Egypt)

Primary Outcome Measures

Name	Time	Method
change in Dermoscopy photoaging scale	assesed every month for 6 months	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.