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Completed

NCT Number: NCT04080869

Retinyl Palmitate-loaded Ethosomes in Acne Vulgaris

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

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Key information

Conditions

Facial Acne Vulgaris Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Assiut University Hospital

Asyut, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

retinyl palmitate

Drug

topical retinyl palmitate loaded ethosomes

Other names: retinyl palmitate ethosomes

Tretinoin

Drug

topical tretinoin

Other names: classic retinoid

Primary outcomes

  1. 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

  2. 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)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 6, 2019
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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