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Efficacy of Topical Antioxidants in Tretment of Photoaging

Primary Purpose

Photoaging

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Selenium Amino Acid Chelate (Selenium ACE cream)
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Photoaging focused on measuring topical antioxidants, photoaged skin

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Group 1(treatment group)

    Group 2 (positive control)

    Group 3 (Negative control)

    Arm 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)

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 19, 2021
    Last Updated
    April 18, 2021
    Sponsor
    Sohag University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04835259
    Brief Title
    Efficacy of Topical Antioxidants in Tretment of Photoaging
    Official Title
    Efficacy of a Combination of Topical Antioxidants in Tretment of Photoaged Skin:A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2021 (Anticipated)
    Primary Completion Date
    April 2022 (Anticipated)
    Study Completion Date
    June 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sohag University

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. 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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Photoaging
    Keywords
    topical antioxidants, photoaged skin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1(treatment group)
    Arm Type
    Active Comparator
    Arm 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)
    Arm Title
    Group 2 (positive control)
    Arm Type
    Active Comparator
    Arm Description
    Topical application of a retinoid (tretinoin 0.05%) cream once daily at night for 6 months (Acretin 0.05% cream Jamjoom pharmaceuticals, Egypt)
    Arm Title
    Group 3 (Negative control)
    Arm Type
    Placebo Comparator
    Arm Description
    Topical application of a panthenol cream once daily at night for 6 months (panthenol 2% cream, El Nile company, Egypt)
    Intervention Type
    Drug
    Intervention Name(s)
    Selenium Amino Acid Chelate (Selenium ACE cream)
    Other Intervention Name(s)
    topical retinoid (Acretin 0.05% cream), topical panthenol (Panthenol cream)
    Intervention Description
    application of a topical agent over the whole face for 6 months
    Primary Outcome Measure Information:
    Title
    change in Dermoscopy photoaging scale
    Description
    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.
    Time Frame
    assesed every month for 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    esraa ismail
    Phone
    00201000509636
    Email
    esraasalah123@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    esraa ismail
    Organizational Affiliation
    Sohag University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy of Topical Antioxidants in Tretment of Photoaging

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