Facial Acne Vulgaris
Conditions
Keywords
acne vulgaris, retinoids, retinyl palmitate, ethosomes
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
Interventions
topical retinyl palmitate loaded ethosomes
DRUGTretinoin
topical tretinoin
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
The topical preparations are packed in non-identifiable jars and coded by a person who is not involved in the study the patient.
Intervention model description
A Prospective, split face comparative clinical study
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Egypt
Outcome results
None listed