Retinyl Palmitate-loaded Ethosomes in Acne Vulgaris
Primary Purpose
Facial Acne Vulgaris
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
retinyl palmitate
Tretinoin
Sponsored by
About this trial
This is an interventional treatment trial for Facial Acne Vulgaris focused on measuring acne vulgaris, retinoids, retinyl palmitate, ethosomes
Eligibility Criteria
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
Sites / Locations
- Assiut University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
retinyl palmitate ethosomes arm
tretinoin arm
Arm Description
All patients will be instructed to apply a thin film of the new formula on one side of the face
All patients will be instructed to apply a thin film of topical retinoid cream on the other side of the face
Outcomes
Primary Outcome Measures
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
assessment of tolerability: interviewing the patients
interviewing the patients about any sign/symptom of adverse reactions (erythema, peeling, burning sensation, dryness and pruritus)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04080869
Brief Title
Retinyl Palmitate-loaded Ethosomes in Acne Vulgaris
Official Title
Formulation of Retinyl Palmitate-loaded Topical Ethosomes for Treatment of Acne Vulgaris: a Split-face Comparative Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
August 28, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
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
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Acne Vulgaris
Keywords
acne vulgaris, retinoids, retinyl palmitate, ethosomes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A Prospective, split face comparative clinical study
Masking
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
retinyl palmitate ethosomes arm
Arm Type
Experimental
Arm Description
All patients will be instructed to apply a thin film of the new formula on one side of the face
Arm Title
tretinoin arm
Arm Type
Active Comparator
Arm Description
All patients will be instructed to apply a thin film of topical retinoid cream on the other side of the face
Intervention Type
Drug
Intervention Name(s)
retinyl palmitate
Other Intervention Name(s)
retinyl palmitate ethosomes
Intervention Description
topical retinyl palmitate loaded ethosomes
Intervention Type
Drug
Intervention Name(s)
Tretinoin
Other Intervention Name(s)
classic retinoid
Intervention Description
topical tretinoin
Primary Outcome Measure Information:
Title
Efficacy of the medication: number of inflammatory, non-inflammatory and total lesions
Description
counting the number of inflammatory, non-inflammatory and total lesions at first and every week during the treatment
Time Frame
at first and every 2 weeks during the 6-week treatment period from starting the topical application
Title
assessment of tolerability: interviewing the patients
Description
interviewing the patients about any sign/symptom of adverse reactions (erythema, peeling, burning sensation, dryness and pruritus)
Time Frame
every 2 weeks during the 6-week treatment period from starting the topical application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara M Awad, MD
Organizational Affiliation
Department of Dermatology, Venereology and Andrology, Assiut University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
data that underlie results in a publication
IPD Sharing Time Frame
starting 6 months after publication
Citations:
PubMed Identifier
12842345
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. doi: 10.1016/s0378-5173(03)00268-0.
Results Reference
background
PubMed Identifier
18532922
Citation
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.
Results Reference
result
PubMed Identifier
16247244
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. doi: 10.1159/000089138.
Results Reference
result
Learn more about this trial
Retinyl Palmitate-loaded Ethosomes in Acne Vulgaris
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