CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
retinyl palmitate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04080869
NCT04080869Phase 2Completed

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

Assiut University·interventional·Posted Sep 6, 2019·Updated Nov 14, 2022

In Brief

A Phase 2 clinical trial evaluating retinyl palmitate and Tretinoin for Facial Acne Vulgaris. Completed, enrolled 20 participants across 1 site.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedSep 6, 2019
Enrollment StartJan 6, 2020
Primary CompletionAug 28, 2020
Study CompletionNov 30, 2020
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 6.8 years ago

Interventions

retinyl palmitatedrug

topical retinyl palmitate loaded ethosomes

Tretinoindrug

topical tretinoin