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Efficacy of Topical Antioxidants in Tretment of Photoaging

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04835259
Collaborator
(none)
90
Enrollment
3
Arms
14
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Selenium Amino Acid Chelate (Selenium ACE cream)
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of a Combination of Topical Antioxidants in Tretment of Photoaged Skin:A Randomized Controlled Trial
Anticipated Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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)

Drug: Selenium Amino Acid Chelate (Selenium ACE cream)
application of a topical agent over the whole face for 6 months
Other Names:
  • topical retinoid (Acretin 0.05% cream)
  • topical panthenol (Panthenol cream)

    		•
    Active Comparator: 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)

    Drug: Selenium Amino Acid Chelate (Selenium ACE cream)
    application of a topical agent over the whole face for 6 months
    Other Names:
  • topical retinoid (Acretin 0.05% cream)
  • topical panthenol (Panthenol cream)

    		•
    Placebo Comparator: Group 3 (Negative control)

    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)
    application of a topical agent over the whole face for 6 months
    Other Names:
  • topical retinoid (Acretin 0.05% cream)
  • topical panthenol (Panthenol cream)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sohag University

    Investigators

    • Principal Investigator: esraa ismail, Sohag University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    esraa ismail, assistant lecturer, Sohag University
    ClinicalTrials.gov Identifier:
    NCT04835259
    Other Study ID Numbers:
    • Soh-Med-21-01-10
    First Posted:
    Apr 8, 2021
    Last Update Posted:
    Apr 20, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by esraa ismail, assistant lecturer, Sohag University
    topical antioxidants
    photoaged skin
    Additional relevant MeSH terms:
    Skin Diseases
    Selenium

    Study Results

    No Results Posted as of Apr 20, 2021