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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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) |
|
| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manuka honey( MgO 850, UMF+20) loaded nano-formulation | Other | Assessment of the efficacy of manuka-loaded nano-formulation and manuka honey-loaded gel on the improvement of acne vulgaris |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evaluation | Clinical evaluation: (Yun Chen MM et al.,2023)
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maha Khalifa | Contact | +966561148759 | Mahakhalifa.pharmg@azhar.edu.eg | |
| Maha Khalifa | Contact | +966561148759 | Mahakhalifa.ahmed@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Maha Khalifa | Associate professor of pharmaceutics | Study Director |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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Prospective interventional randomized clinical trial
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The intervention of each group
|
| 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 |