Efficacy of Topical Antioxidants in Tretment of Photoaging

Study Overview
=================
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

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

Conditions
-----------------
Photoaging

Intervention / Treatment
-----------------
* Drug: Selenium Amino Acid Chelate (Selenium ACE cream)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1(treatment group)<br>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) | Drug: Selenium Amino Acid Chelate (Selenium ACE cream)<br>* application of a topical agent over the whole face for 6 months<br>* Other names: topical panthenol (Panthenol cream);|
| Active Comparator: Group 2 (positive control)<br>Topical application of a retinoid (tretinoin 0.05%) cream once daily at night for 6 months (Acretin 0.05% cream Jamjoom pharmaceuticals, Egypt) | Drug: Selenium Amino Acid Chelate (Selenium ACE cream)<br>* application of a topical agent over the whole face for 6 months<br>* Other names: topical panthenol (Panthenol cream);|
| Placebo Comparator: Group 3 (Negative control)<br>Topical application of a panthenol cream once daily at night for 6 months (panthenol 2% cream, El Nile company, Egypt) | Drug: Selenium Amino Acid Chelate (Selenium ACE cream)<br>* application of a topical agent over the whole face for 6 months<br>* Other names: topical panthenol (Panthenol cream);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
topical antioxidants, photoaged skin