Retinyl Palmitate-loaded Ethosomes in Acne Vulgaris

November 10, 2022 updated by: Sara Mohamed Awad, Assiut University

Formulation of Retinyl Palmitate-loaded Topical Ethosomes for Treatment of Acne Vulgaris: a Split-face Comparative Clinical Study

Acne is a chronic inflammatory dermatosis of the pilosebaceous unit. Topical treatment is the first choice in mild and moderate cases of acne, especially topical retinoids. Although topical retinoids are very effective in the treatment of acne, local cutaneous irritation including burning, itching, erythema, peeling or dryness, is observed in a considerable number of patients, resulting in low patient compliance, compromising the efficacy of the therapy.

Several approaches have been proposed to address these concerns, including the use of esters of retinoic acid (RA) and RA precursors, such as retinol and retinaldehyde, or novel drug delivery systems, which present the potential for controlled release, in turn reducing the aforementioned occurrences.

Encapsulation of retinoids into vesicular carriers as liposomes and ethosomes and nanoparticulate carriers can significantly improve their effects for the treatment of acne compared with commercial formulations , providing better tolerability of irritating retinoid.

The aim of work is to assess the efficacy and tolerability of the topical application of Retinyl Palmitate-loaded ethosome formulation in the treatment of acne vulgaris in comparison to conventional formulation of classic retinoids

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut university hospital

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

12 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with facial mild to moderate acne vulgaris
  • Patients aged 12-40 years old

Exclusion Criteria:

  • Pregnant females
  • Patients with skin condition of the face such as rosacea, perioral dermatitis, atopic or seborrheic dermatitis or psoriasis.
  • Patients with known hypersensitivity to preparations containing retinoid.
  • Patients who take any other cocomitant systemic or topical medications for acne vulgaris

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: retinyl palmitate ethosomes arm
All patients will be instructed to apply a thin film of the new formula on one side of the face
Drug: retinyl palmitate
topical retinyl palmitate loaded ethosomes
Other Names:
  • retinyl palmitate ethosomes
Active Comparator: tretinoin arm
All patients will be instructed to apply a thin film of topical retinoid cream on the other side of the face
Drug: Tretinoin
topical tretinoin
Other Names:
  • classic retinoid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of the medication: number of inflammatory, non-inflammatory and total lesions
Time Frame: at first and every 2 weeks during the 6-week treatment period from starting the topical application
counting the number of inflammatory, non-inflammatory and total lesions at first and every week during the treatment
at first and every 2 weeks during the 6-week treatment period from starting the topical application
assessment of tolerability: interviewing the patients
Time Frame: every 2 weeks during the 6-week treatment period from starting the topical application
interviewing the patients about any sign/symptom of adverse reactions (erythema, peeling, burning sensation, dryness and pruritus)
every 2 weeks during the 6-week treatment period from starting the topical application

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Sara M Awad, MD, Department of Dermatology, Venereology and Andrology, Assiut University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 6, 2020

Primary Completion (Actual)

August 28, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

September 4, 2019

First Submitted That Met QC Criteria

September 5, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 10, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP-AV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

data that underlie results in a publication

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

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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