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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
102
Assessment of the efficacy of manuka-loaded nano-formulation and manuka honey-loaded gel on the improvement of acne vulgaris
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%
Time frame: 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).
Time frame: 4 weeks
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.
Time frame: 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
Time frame: 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
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Time frame: 4 weeks