Retinyl Palmitate-loaded Ethosomes in Acne Vulgaris

Assiut University20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Facial Acne Vulgaris

Eligibility

Sex: ALLMin age: 12 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Efficacy of the medication: number of inflammatory, non-inflammatory and total lesions

counting the number of inflammatory, non-inflammatory and total lesions at first and every week during the treatment

Time frame: at first and every 2 weeks during the 6-week treatment period from starting the topical application

assessment of tolerability: interviewing the patients

interviewing the patients about any sign/symptom of adverse reactions (erythema, peeling, burning sensation, dryness and pruritus)

Time frame: every 2 weeks during the 6-week treatment period from starting the topical application