Acne VulgarisNCT06175819
Efficacy of Manuka Honey Nano-Formulation in the Treatment of Acne Vulgaris
A study testing Manuka honey( MgO 850, UMF+20) loaded nano-formulation in people with Acne Vulgaris, run by Al-Azhar University.
Trial summary
The present study aims to manufacture manuka honey-loaded nano-formulation using natural materials as a potent tissue-healing remedy and compare it to commercially available antimicrobial therapy in order to reduce the severity and recurrences of skin lesions. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Manuka honey( MgO 850, UMF+20) loaded nano-formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to 11 Sep 2024
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mild to moderate acne vulgaris patients.Patients will be assessed for severity of acne by Global acne grading system (GAGS).
- Age of patients: 18-40 years.
- Sex: both sexes.
Who cannot join
- Pregnancy and lactation.
- severe acne vulgaris.
- exogenous acne as industrial or cosmetic causes.
- Patients with photodermatitis or allergic dermatitis.
- serious or systemic illnesses such as liver and renal dysfunction.
- Patients with radiotherapy, cryotherapy, cutaneous malignant tumors, and patients suffer from mental illnesses.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Manuka Honey Nano-Formulatin on the Clinical Improvement and Inflammatory Markers Reduction in Patients With Acne Vulgaris
The present study aims to manufacture manuka honey-loaded nano-formulation using natural materials as a potent tissue-healing remedy and compare it to commercially available antimicrobial therapy in order to reduce the severity and recurrences of skin lesions.
Read the detailed description
It was found that patients with acne suffer from lower self-esteem, depression, anxiety, and social isolation as a result of papules, pustules, nodules, cysts, and scarring. Moreover, a common complication of acne is residual post-inflammatory hyperpigmentation and acne scaring which cause further psychological and social distress. Collectively, these factors explain the reduction of quality of life .
The intervention for AV treatment has been unaltered throughout last years. There is a global shift from antibiotics concerning limiting their use due to increasing antibiotic resistance. Hence, it is imperative to provide natural products as another modality of treatment.
Manuka honey (MH) is a mono-floral honey harvested by honeybees (Apis mellifera) after pollinating and collecting nectar primarily from the Manuka tree. MH's anti-inflammatory and broad-spectrum antibacterial activity is due to its major ingredients, hydrogen peroxide H2O2 produced enzymatically, non-peroxidase methylglyoxal (MGO), and the peptide bee defensin-1 which has antimicrobial action. Furthermore, MH inhibits bacterial growth by high osmolality and low pH. A high MGO content MH nano-formulation will be fabricated to serve as a vehicle for its topical delivery.
- Conditions
- Acne Vulgaris
- Being tested
- Manuka honey( MgO 850, UMF+20) loaded nano-formulation
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manuka honey( MgO 850, UMF+20) loaded nano-formulationOther
Also called Manuka honey ( MgO 850, UMF+20)loaded gel
Assessment of the efficacy of manuka-loaded nano-formulation and manuka honey-loaded gel on the improvement of acne vulgaris
| Study group | Role | What they receive |
|---|---|---|
| Manuka nanoformulation group | Experimental | This group will apply Manuka honey ( MgO 850, UMF+20) nanoformulation on the face lesions 2 times daily for 28 days or cure of lesions (Arm 1) Receives: Other: Manuka honey( MgO 850, UMF+20) loaded nano-formulation |
| Manuka honey gel group | Experimental | This group will apply Manuka honey ( MgO 850, UMF+20) gel on the face lesions 2 times daily for 28 days or cure of lesions (Arm 2) Receives: Other: Manuka honey( MgO 850, UMF+20) loaded nano-formulation |
| clindamycin commercial gel | Active comparator | This group will apply clindamycin commercial gel (Clindamycin 1%gel,European pharmaceuticals, Alex, Egypt) on the face lesions 2 times daily for 28 days or cure of lesions (Arm 3) Receives: Other: Manuka honey( MgO 850, UMF+20) loaded nano-formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation
Clinical evaluation: (Yun Chen MM et al.,2023)
- cure :Reduction of lesion area ≥90%
- Significant effect: The lesion area was reduced by 60%-89%
- Effective: Skin lesion area reduced by 30%-59%
- Invalid: Reduction of lesion area ≤29%
- cure :Reduction of lesion area ≥90%
- Significant effect: The lesion area was reduced by 60%-89%
- Effective: Skin lesion area reduced by 30%-59%
- Invalid: Reduction of lesion area ≤29%
Measured: 4 weeks
Acne severity evaluation
Acne severity evaluation :
The skin lesion scores were calculated before treatment and 4 weeks after treatment according to Global acne grading system (GAGS). (Yun Chen MM et al.,2023).
Measured: 4 weeks
Secondary outcomes (3)
Specific parameters (interleukin-1 beta ) (IL-1β)measurement
A venous Plasma samples will be obtained from all patients at first visit and after 4 weeks of treatment.
The assay will be done using commercially available enzyme-linked immunosorbent assay (ELISA) kits before and after 4 weeks of treatment.
The assay will be performed according to the manufacturer's instructions.
Measured: 4 weeks
Specific parameter interleukin-17 (IL-17) measurement
A venous Plasma samples will be obtained from all patients at first visit and after 4 weeks of treatment.
The assay will be done using commercially available enzyme-linked immunosorbent assay (ELISA) kits before and after 4 weeks of treatment.
The assay will be performed according to the manufacturer's instructions
Measured: 4 weeks
Specific parameter C-reactive protein (CRP) measurement
A venous Plasma samples will be obtained from all patients at first visit and after 4 weeks of treatment.
The assay will be done using commercially available enzyme-linked immunosorbent assay (ELISA) kits before and after 4 weeks of treatment.
The assay will be performed according to the manufacturer's instructions
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study startJan 2024 (estimated)
- Primary completion11 Apr 2024 (estimated)
- Study completion11 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective interventional randomized clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha khalifa, Al-Azhar University
- Investigators
- Maha Khalifa, Study director, Associate professor of pharmaceutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175819
- Sponsor's protocol ID
- Manuka honey nanoformulation
- Status last verified
- Dec 2023
- First submitted
- 19 Nov 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Manuka Honey Nano-Formulatin on the Clinical Improvement and Inflammatory Markers Reduction in Patients With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT06175819
- Acronym / sponsor ID
- Manuka honey nanoformulation
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- 11 Apr 2024 (estimated)
- Study completion
- 11 Sep 2024 (estimated)
- First posted
- 19 Dec 2023 (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.
The present study aims to manufacture manuka honey-loaded nano-formulation using natural materials as a potent tissue-healing remedy and compare it to commercially available antimicrobial therapy in order to reduce the severity and recurrences of skin lesions.
Detailed description
It was found that patients with acne suffer from lower self-esteem, depression, anxiety, and social isolation as a result of papules, pustules, nodules, cysts, and scarring. Moreover, a common complication of acne is residual post-inflammatory hyperpigmentation and acne scaring which cause further psychological and social distress. Collectively, these factors explain the reduction of quality of life .
The intervention for AV treatment has been unaltered throughout last years. There is a global shift from antibiotics concerning limiting their use due to increasing antibiotic resistance. Hence, it is imperative to provide natural products as another modality of treatment.
Manuka honey (MH) is a mono-floral honey harvested by honeybees (Apis mellifera) after pollinating and collecting nectar primarily from the Manuka tree. MH's anti-inflammatory and broad-spectrum antibacterial activity is due to its major ingredients, hydrogen peroxide H2O2 produced enzymatically, non-peroxidase methylglyoxal (MGO), and the peptide bee defensin-1 which has antimicrobial action. Furthermore, MH inhibits bacterial growth by high osmolality and low pH. A high MGO content MH nano-formulation will be fabricated to serve as a vehicle for its topical delivery.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Prospective interventional randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Manuka nanoformulation group | Experimental | Other: Manuka honey( MgO 850, UMF+20) loaded nano-formulationThis group will apply Manuka honey ( MgO 850, UMF+20) nanoformulation on the face lesions 2 times daily for 28 days or cure of lesions (Arm 1) |
| Manuka honey gel group | Experimental | Other: Manuka honey( MgO 850, UMF+20) loaded nano-formulationThis group will apply Manuka honey ( MgO 850, UMF+20) gel on the face lesions 2 times daily for 28 days or cure of lesions (Arm 2) |
| clindamycin commercial gel | Active comparator | Other: Manuka honey( MgO 850, UMF+20) loaded nano-formulationThis group will apply clindamycin commercial gel (Clindamycin 1%gel,European pharmaceuticals, Alex, Egypt) on the face lesions 2 times daily for 28 days or cure of lesions (Arm 3) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Mild to moderate acne vulgaris patients.Patients will be assessed for severity of acne by Global acne grading system (GAGS).
- Age of patients: 18-40 years.
- Sex: both sexes.
Key exclusion criteria (6 listed)
- Pregnancy and lactation.
- severe acne vulgaris.
- exogenous acne as industrial or cosmetic causes.
- Patients with photodermatitis or allergic dermatitis.
- serious or systemic illnesses such as liver and renal dysfunction.
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 |
|---|---|---|
| Manuka honey( MgO 850, UMF+20) loaded nano-formulationAlso: Manuka honey ( MgO 850, UMF+20)loaded gelAssessment of the efficacy of manuka-loaded nano-formulation and manuka honey-loaded gel on the improvement of acne vulgaris | Other | Manuka honey gel group, Manuka nanoformulation group, clindamycin commercial gel |
Primary outcome
Clinical evaluation
Time frame: 4 weeks
Clinical evaluation: (Yun Chen MM et al.,2023) * cure :Reduction of lesion area ≥90% * Significant effect: The lesion area was reduced by 60%-89% * Effective: Skin lesion area reduced by 30%-59% * Invalid: Reduction of lesion area ≤29% * cure :Reduction of lesion area ≥90% * Significant effect: The lesion area was reduced by 60%-89% * Effective: Skin lesion area reduced by 30%-59% * Invalid: Reduction of lesion area ≤29%
Acne severity evaluation
Time frame: 4 weeks
Acne severity evaluation : The skin lesion scores were calculated before treatment and 4 weeks after treatment according to Global acne grading system (GAGS). (Yun Chen MM et al.,2023).
3 secondary outcomes
Specific parameters (interleukin-1 beta ) (IL-1β)measurement
Time frame: 4 weeks
Specific parameter interleukin-17 (IL-17) measurement
Time frame: 4 weeks
Specific parameter C-reactive protein (CRP) measurement
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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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.
Maha Khalifa study director
Associate professor of pharmaceutics
Questions about this trial
What is this clinical trial studying?
A study testing Manuka honey( MgO 850, UMF+20) loaded nano-formulation in people with Acne Vulgaris, run by Al-Azhar University.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maha Khalifa (+966561148759, Mahakhalifa.pharmg@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation (time frame: 4 weeks). 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?
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 19 Dec 2023.