Efficacy of Topical Antioxidants in Tretment of Photoaging

NCT04835259 | Unknown DMC

• 1 other identifier: Soh-Med-21-01-10
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Photoaging

Keywords

topical antioxidants; photoaged skin

Outcome Measures

Primary Outcomes (1)

• 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.

  assesed every month for 6 months

Study Arms (3)

Group 1(treatment group)

ACTIVE COMPARATOR

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)

Group 2 (positive control)

ACTIVE COMPARATOR

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)

Group 3 (Negative control)

PLACEBO COMPARATOR

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)

Interventions

Selenium Amino Acid Chelate (Selenium ACE cream) DRUG

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

Also known as: topical retinoid (Acretin 0.05% cream), topical panthenol (Panthenol cream)

Group 1(treatment group); Group 2 (positive control); Group 3 (Negative control)

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult volunteers \< 50 years old
• Clinical and dermoscopic features of photoaging.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Interventions

Retinoids; dexpanthenol

Intervention Hierarchy (Ancestors)

Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• esraa ismail

  Sohag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

esraa ismail

CONTACT

00201000509636; esraasalah123@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: April 8, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share