Efficacy of Topical Antioxidants in Tretment of Photoaging

April 18, 2021 updated by: esraa ismail, Sohag University

Efficacy of a Combination of Topical Antioxidants in Tretment of Photoaged Skin:A Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Dermoscopy photoaging scale
Time Frame: 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.
assesed every month for 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Principal Investigator: esraa ismail, Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2021

Primary Completion (ANTICIPATED)

April 1, 2022

Study Completion (ANTICIPATED)

June 1, 2022

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

April 4, 2021

First Posted (ACTUAL)

April 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 18, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-01-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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