Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2020-01-06
2020-11-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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retinyl palmitate ethosomes arm
All patients will be instructed to apply a thin film of the new formula on one side of the face
retinyl palmitate
topical retinyl palmitate loaded ethosomes
tretinoin arm
All patients will be instructed to apply a thin film of topical retinoid cream on the other side of the face
Tretinoin
topical tretinoin
Interventions
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retinyl palmitate
topical retinyl palmitate loaded ethosomes
Tretinoin
topical tretinoin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients aged 12-40 years old
Exclusion Criteria
* 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
12 Years
40 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Sara Mohamed Awad
Assistant Professor
Principal Investigators
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Sara M Awad, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Dermatology, Venereology and Andrology, Assiut University Hospital
Locations
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Assiut University Hospital
Asyut, , Egypt
Countries
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References
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Manconi M, Valenti D, Sinico C, Lai F, Loy G, Fadda AM. Niosomes as carriers for tretinoin. II. Influence of vesicular incorporation on tretinoin photostability. Int J Pharm. 2003 Jul 24;260(2):261-72. doi: 10.1016/s0378-5173(03)00268-0.
Castro GA, Ferreira LA. Novel vesicular and particulate drug delivery systems for topical treatment of acne. Expert Opin Drug Deliv. 2008 Jun;5(6):665-79. doi: 10.1517/17425247.5.6.665.
Date AA, Naik B, Nagarsenker MS. Novel drug delivery systems: potential in improving topical delivery of antiacne agents. Skin Pharmacol Physiol. 2006;19(1):2-16. doi: 10.1159/000089138.
Other Identifiers
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RP-AV
Identifier Type: -
Identifier Source: org_study_id
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