Efficacy of Manuka Honey Nano-Formulation in the Treatment of Acne Vulgaris

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Manuka Honey Nano-Formulatin on the Clinical Improvement and Inflammatory Markers Reduction in Patients With Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Other: Manuka honey( MgO 850, UMF+20) loaded nano-formulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective interventional randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manuka nanoformulation group<br>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) | Other: Manuka honey( MgO 850, UMF+20) loaded nano-formulation<br>* Assessment of the efficacy of manuka-loaded nano-formulation and manuka honey-loaded gel on the improvement of acne vulgaris<br>* Other names: Manuka honey ( MgO 850, UMF+20)loaded gel;|
| Experimental: Manuka honey gel group<br>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) | Other: Manuka honey( MgO 850, UMF+20) loaded nano-formulation<br>* Assessment of the efficacy of manuka-loaded nano-formulation and manuka honey-loaded gel on the improvement of acne vulgaris<br>* Other names: Manuka honey ( MgO 850, UMF+20)loaded gel;|
| Active Comparator: clindamycin commercial gel<br>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) | Other: Manuka honey( MgO 850, UMF+20) loaded nano-formulation<br>* Assessment of the efficacy of manuka-loaded nano-formulation and manuka honey-loaded gel on the improvement of acne vulgaris<br>* Other names: Manuka honey ( MgO 850, UMF+20)loaded gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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% | 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). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 4 weeks |