Facial Acne VulgarisPhase 2NCT04080869
Retinyl Palmitate-loaded Ethosomes in Acne Vulgaris
A Phase 2 study testing retinyl palmitate and Tretinoin in people with Facial Acne Vulgaris, run by Assiut University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Facial Acne Vulgaris
- What is being tested?
- retinyl palmitate and Tretinoin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jan 2020to 30 Nov 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with facial mild to moderate acne vulgaris
- Patients aged 12-40 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Formulation of Retinyl Palmitate-loaded Topical Ethosomes for Treatment of Acne Vulgaris: a Split-face Comparative Clinical Study
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.
Read more
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
- Being tested
- retinyl palmitate, Tretinoin
- Keywords
- acne vulgaris, retinoids, retinyl palmitate, ethosomes
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retinyl palmitateDrug
Also called retinyl palmitate ethosomes
topical retinyl palmitate loaded ethosomes
TretinoinDrug
Also called classic retinoid
topical tretinoin
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Tretinoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: every 2 weeks during the 6-week treatment period from starting the topical application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start6 Jan 2020
- Primary completion28 Aug 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Facial Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Prospective, split face comparative clinical study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mohamed Awad, Assiut University
- Investigators
- Sara M Awad, MD, Principal investigator, Department of Dermatology, Venereology and Andrology, Assiut University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080869
- Sponsor's protocol ID
- RP-AV
- Status last verified
- Nov 2022
- First submitted
- 4 Sep 2019
- Last updated
- 14 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data that underlie results in a publication
Publications
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.
PubMed 12842345Castro 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.
PubMed 18532922Date 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.
PubMed 16247244
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formulation of Retinyl Palmitate-loaded Topical Ethosomes for Treatment of Acne Vulgaris: a Split-face Comparative Clinical Study
- ClinicalTrials.gov ID
- NCT04080869
- Acronym / sponsor ID
- RP-AV
- Conditions
- Facial Acne Vulgaris
- Keywords
- acne vulgaris, retinoids, retinyl palmitate, ethosomes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A Prospective, split face comparative clinical study
| Arm | Type | Receives |
|---|---|---|
| retinyl palmitate ethosomes arm | Experimental | Drug: retinyl palmitateAll patients will be instructed to apply a thin film of the new formula on one side of the face |
| tretinoin arm | Active comparator | Drug: TretinoinAll patients will be instructed to apply a thin film of topical retinoid cream on the other side of the face |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients with facial mild to moderate acne vulgaris
- Patients aged 12-40 years old
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retinyl palmitateAlso: retinyl palmitate ethosomestopical retinyl palmitate loaded ethosomes | Drug | retinyl palmitate ethosomes arm |
| TretinoinAlso: classic retinoidtopical tretinoin | Drug | tretinoin arm |
Primary outcome
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Background: PubMed 12842345Manconi 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 publication: PubMed 18532922Castro 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 publication: PubMed 16247244Date 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.
- Individual participant dataSharing planned: Yes. data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara M Awad, MD principal investigator
Department of Dermatology, Venereology and Andrology, Assiut University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing retinyl palmitate and Tretinoin in people with Facial Acne Vulgaris, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04080869, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.