NCT04080869

Retinyl Palmitate-loaded Ethosomes in Acne Vulgaris

Completed Phase 2 Last updated 14 November 2022

What this trial tests

Phase 2 trial testing retinyl palmitate in Facial Acne Vulgaris in 20 participants. Completed in 30 November 2020.

Timeline

6 January 2020

Primary endpoint
28 August 2020

30 November 2020

Quick facts

Lead sponsor	Assiut University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	20
Start date	6 January 2020
Primary completion	28 August 2020
Estimated completion	30 November 2020
Sites	1 location across Egypt

Drugs / interventions tested

• retinyl palmitate — full drug profile →
• Tretinoin (TRETINOIN) — full drug profile →

Conditions studied

• Facial Acne Vulgaris — all drugs for Facial Acne Vulgaris →

Sponsor

Assiut University

Who can join

Adults 12 to 40, any sex, with Facial Acne Vulgaris. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tailoring of Retinyl Palmitate-Based Ethosomal Hydrogel as a Novel Nanoplatform for Acne Vulgaris Management: Fabrication, Optimization, and Clinical Evaluation Employing a Split-Face Comparative Study.
   Salem HF, Kharshoum RM, Awad SM, Ahmed Mostafa M, et al · · 2021 · cited 26× · PMID 34211271 · DOI 10.2147/ijn.s301597
2. Progress in Topical and Transdermal Drug Delivery Research-Focus on Nanoformulations.
   Lunter D, Klang V, Eichner A, Savic SM, et al · · 2024 · cited 22× · PMID 38931938 · DOI 10.3390/pharmaceutics16060817