Retinyl Palmitate-loaded Ethosomes in Acne Vulgaris

Assiut University

Status and phase: Completed; Phase 2

Conditions: Facial Acne Vulgaris

Treatments: Drug: Tretinoin; Drug: retinyl palmitate

Study type: Interventional

Funder types: Other

Identifiers

NCT04080869

RP-AV

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

retinyl palmitate ethosomes arm

Experimental group

Description:

All patients will be instructed to apply a thin film of the new formula on one side of the face

Treatment:

Drug: retinyl palmitate

tretinoin arm

Active Comparator group

Description:

All patients will be instructed to apply a thin film of topical retinoid cream on the other side of the face

Treatment:

Drug: Tretinoin