Retinyl Palmitate-loaded Ethosomes in Acne Vulgaris

NCT ID: NCT04080869

Last Updated: 2022-11-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2020-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Facial Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A Prospective, split face comparative clinical study
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
The topical preparations are packed in non-identifiable jars and coded by a person who is not involved in the study the patient.

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

Group Type EXPERIMENTAL

retinyl palmitate

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Tretinoin

Intervention Type DRUG

topical tretinoin

Interventions

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retinyl palmitate

topical retinyl palmitate loaded ethosomes

Intervention Type DRUG

Tretinoin

topical tretinoin

Intervention Type DRUG

Other Intervention Names

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retinyl palmitate ethosomes classic retinoid

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Sara Mohamed Awad

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Egypt

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.

Reference Type BACKGROUND
PMID: 12842345 (View on PubMed)

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.

Reference Type RESULT
PMID: 18532922 (View on PubMed)

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.

Reference Type RESULT
PMID: 16247244 (View on PubMed)

Other Identifiers

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RP-AV

Identifier Type: -

Identifier Source: org_study_id

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