Retinyl Palmitate-loaded Ethosomes in Acne Vulgaris

Facial Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04080869
• Other study ID #: RP-AV
• Status: Completed
• Phase: Phase 2
• Start date: January 6, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: November 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 30, 2020
• Est. primary completion date: August 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris
• Facial Acne Vulgaris

Intervention

Drug:
• retinyl palmitate
topical retinyl palmitate loaded ethosomes
• Tretinoin
topical tretinoin

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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 . Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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