Retinyl Palmitate-loaded Ethosomes in Acne Vulgaris

Study Overview
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Brief Summary
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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

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

Conditions
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Facial Acne Vulgaris

Intervention / Treatment
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* Drug: retinyl palmitate
* Drug: Tretinoin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Prospective, split face comparative clinical study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: retinyl palmitate ethosomes arm<br>All patients will be instructed to apply a thin film of the new formula on one side of the face | Drug: retinyl palmitate<br>* topical retinyl palmitate loaded ethosomes<br>* Other names: retinyl palmitate ethosomes;|
| Active Comparator: tretinoin arm<br>All patients will be instructed to apply a thin film of topical retinoid cream on the other side of the face | Drug: Tretinoin<br>* topical tretinoin<br>* Other names: classic retinoid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | every 2 weeks during the 6-week treatment period from starting the topical application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne vulgaris, retinoids, retinyl palmitate, ethosomes