Retinyl Palmitate-loaded Ethosomes in Acne Vulgaris

NCT04080869 | Completed Phase 2

• 1 other identifier: RP-AV
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Facial Acne Vulgaris

Keywords

acne vulgaris; retinoids; retinyl palmitate; ethosomes

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

retinyl palmitate ethosomes arm

EXPERIMENTAL

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

Drug: retinyl palmitate

tretinoin arm

ACTIVE COMPARATOR

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

Drug: Tretinoin

Interventions

retinyl palmitate DRUG

topical retinyl palmitate loaded ethosomes

Also known as: retinyl palmitate ethosomes

retinyl palmitate ethosomes arm

Tretinoin DRUG

topical tretinoin

Also known as: classic retinoid

tretinoin arm

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with facial mild to moderate acne vulgaris
• Patients aged 12-40 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

Location

Related Publications (3)

• 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.

  PMID: 12842345 BACKGROUND

• 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.

  PMID: 18532922 RESULT

• 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.

  PMID: 16247244 RESULT

MeSH Terms

Conditions

Acne Vulgaris

Interventions

retinol palmitate; Tretinoin

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Sara M Awad, MD

  Department of Dermatology, Venereology and Andrology, Assiut University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The topical preparations are packed in non-identifiable jars and coded by a person who is not involved in the study the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A Prospective, split face comparative clinical study

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 6, 2019
• Study Start: January 6, 2020
• Primary Completion: August 28, 2020
• Study Completion: November 30, 2020
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: starting 6 months after publication

Locations

EG (1)