Efficacy of Topical Antioxidants in Tretment of Photoaging

NCT ID: NCT04835259

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2022-06-30

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

Conditions

Photoaging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1(treatment group)

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 Type: ACTIVE_COMPARATOR

Selenium Amino Acid Chelate (Selenium ACE cream)

Intervention Type: DRUG

application of a topical agent over the whole face for 6 months

Group 2 (positive control)

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

Group Type: ACTIVE_COMPARATOR

Selenium Amino Acid Chelate (Selenium ACE cream)

Intervention Type: DRUG

application of a topical agent over the whole face for 6 months

Group 3 (Negative control)

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

Group Type: PLACEBO_COMPARATOR

Selenium Amino Acid Chelate (Selenium ACE cream)

Intervention Type: DRUG

application of a topical agent over the whole face for 6 months

Interventions

Selenium Amino Acid Chelate (Selenium ACE cream)

application of a topical agent over the whole face for 6 months

Intervention Type: DRUG

Other Intervention Names

topical retinoid (Acretin 0.05% cream); topical panthenol (Panthenol cream)

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

esraa ismail

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

esraa ismail

Role: PRINCIPAL_INVESTIGATOR

Sohag University

Central Contacts

esraa ismail

Role: CONTACT

esraasalah123@yahoo.com

00201000509636

Other Identifiers

Soh-Med-21-01-10

Identifier Type: -

Identifier Source: org_study_id