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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.
•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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1(treatment group) | Active Comparator | 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) | Active Comparator | 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) | Placebo Comparator | Topical application of a panthenol cream once daily at night for 6 months (panthenol 2% cream, El Nile company, Egypt) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selenium Amino Acid Chelate (Selenium ACE cream) | Drug | application of a topical agent over the whole face for 6 months |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| esraa ismail | Contact | 00201000509636 | esraasalah123@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| esraa ismail | Sohag University | Principal Investigator |
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| ID | Term |
|---|---|
| D012176 | Retinoids |
| C007288 | dexpanthenol |
| ID | Term |
|---|---|
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
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|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |