Efficacy of Topical Antioxidants in Tretment of Photoaging

Sohag University

Status: Unknown

Conditions: Photoaging

Treatments: Drug: Selenium Amino Acid Chelate (Selenium ACE cream)

Study type: Interventional

Funder types: Other

Identifiers

NCT04835259

Soh-Med-21-01-10

Details and patient eligibility

About

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.

Full 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

Enrollment: 90 estimated patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups, including a placebo group

Group 1(treatment group)

Active Comparator group

Description:

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)

Treatment:

Drug: Selenium Amino Acid Chelate (Selenium ACE cream)

Group 2 (positive control)

Active Comparator group

Description:

Topical application of a retinoid (tretinoin 0.05%) cream once daily at night for 6 months (Acretin 0.05% cream Jamjoom pharmaceuticals, Egypt)

Treatment:

Drug: Selenium Amino Acid Chelate (Selenium ACE cream)

Group 3 (Negative control)

Placebo Comparator group

Description:

Topical application of a panthenol cream once daily at night for 6 months (panthenol 2% cream, El Nile company, Egypt)

Treatment:

Drug: Selenium Amino Acid Chelate (Selenium ACE cream)