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Retinyl Palmitate-loaded Ethosomes in Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04080869
Recruitment Status : Not yet recruiting
First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Information provided by (Responsible Party):
Sara Mohamed Awad, Assiut University

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

Condition or disease Intervention/treatment Phase
Facial Acne Vulgaris Drug: retinyl palmitate Drug: Tretinoin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Prospective, split face comparative clinical study
Masking: Triple (Participant, Care Provider, 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.
Primary Purpose: Treatment
Official Title: Formulation of Retinyl Palmitate-loaded Topical Ethosomes for Treatment of Acne Vulgaris: a Split-face Comparative Clinical Study
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Vitamin A

Arm Intervention/treatment
Experimental: retinyl palmitate ethosomes arm
All patients will be instructed to apply a thin film of the new formula on one side of the face
Drug: retinyl palmitate
topical retinyl palmitate loaded ethosomes
Other Name: retinyl palmitate ethosomes

Active Comparator: tretinoin arm
All patients will be instructed to apply a thin film of topical retinoid cream on the other side of the face
Drug: Tretinoin
topical tretinoin
Other Name: classic retinoid

Primary Outcome Measures :
  1. Efficacy of the medication: number of inflammatory, non-inflammatory and total lesions [ Time Frame: 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

  2. assessment of tolerability: interviewing the patients [ Time Frame: 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04080869

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Contact: Sara M Awad, MD +2-088-241-3911
Contact: Heba AE Aboutaleb, MD +2-088-241-3911

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Assiut University Hospital
Assiut, Egypt
Sponsors and Collaborators
Assiut University
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Principal Investigator: Sara M Awad, MD Department of Dermatology, Venereology and Andrology, Assiut University Hospital

Publications of Results:
Other Publications:
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Responsible Party: Sara Mohamed Awad, Assistant Professor, Assiut University Identifier: NCT04080869     History of Changes
Other Study ID Numbers: RP-AV
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: data that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: starting 6 months after publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sara Mohamed Awad, Assiut University:
acne vulgaris
retinyl palmitate
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Vitamin A
Retinol palmitate
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Anticarcinogenic Agents
Growth Substances