Retinyl Palmitate-loaded Ethosomes in Acne Vulgaris

Phase 2

Completed

• Conditions: Facial Acne Vulgaris
• Interventions: Drug: retinyl palmitate; Drug: Tretinoin

• Registration Number: NCT04080869
• Lead Sponsor: Assiut University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-05
• Study First Posted: 2019-09-06
• Study Start: 2020-01-06
• Primary Completion: 2020-08-28
• Study Completion: 2020-11-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-10
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
retinyl palmitate ethosomes arm	retinyl palmitate	All patients will be instructed to apply a thin film of the new formula on one side of the face
tretinoin arm	Tretinoin	All patients will be instructed to apply a thin film of topical retinoid cream on the other side of the face

Primary Outcome Measures

Name	Time	Method
Efficacy of the medication: number of inflammatory, non-inflammatory and total lesions	at first and every 2 weeks during the 6-week treatment period from starting the topical application	counting the number of inflammatory, non-inflammatory and total lesions at first and every week during the treatment
assessment of tolerability: interviewing the patients	every 2 weeks during the 6-week treatment period from starting the topical application	interviewing the patients about any sign/symptom of adverse reactions (erythema, peeling, burning sensation, dryness and pruritus)

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt