Clinical trial NCT04080869: Retinyl Palmitate-loaded Ethosomes in Acne Vulgaris
Official title: Formulation of Retinyl Palmitate-loaded Topical Ethosomes for Treatment of Acne Vulgaris: a Split-face Comparative Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Facial Acne Vulgaris
Keywords: acne vulgaris
retinoids
retinyl palmitate
ethosomes
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Prospective, split face comparative clinical study
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of the medication: number of inflammatory, non-inflammatory and total lesions
timeFrame: at first and every 2 weeks during the 6-week treatment period from starting the topical application
measure: assessment of tolerability: interviewing the patients
timeFrame: every 2 weeks during the 6-week treatment period from starting the topical application
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
affiliation: Department of Dermatology, Venereology and Andrology, Assiut University Hospital
name: Sara M Awad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manconi M, Valenti D, Sinico C, Lai F, Loy G, Fadda AM. Niosomes as carriers for tretinoin. II. Influence of vesicular incorporation on tretinoin photostability. Int J Pharm. 2003 Jul 24;260(2):261-72. doi: 10.1016/s0378-5173(03)00268-0.
citation: Castro GA, Ferreira LA. Novel vesicular and particulate drug delivery systems for topical treatment of acne. Expert Opin Drug Deliv. 2008 Jun;5(6):665-79. doi: 10.1517/17425247.5.6.665.
citation: Date AA, Naik B, Nagarsenker MS. Novel drug delivery systems: potential in improving topical delivery of antiacne agents. Skin Pharmacol Physiol. 2006;19(1):2-16. doi: 10.1159/000089138.