Efficacy of Manuka Honey Nano-Formulation in the Treatment of Acne Vulgaris
- Conditions
- Acne Vulgaris
- Interventions
- Other: Manuka honey( MgO 850, UMF+20) loaded nano-formulation
- Registration Number
- NCT06175819
- Lead Sponsor
- Al-Azhar University
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 102
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Manuka nanoformulation group Manuka honey( MgO 850, UMF+20) loaded nano-formulation 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) Manuka honey gel group Manuka honey( MgO 850, UMF+20) loaded nano-formulation 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 Manuka honey( MgO 850, UMF+20) loaded nano-formulation 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)
- Primary Outcome Measures
Name Time Method Acne severity evaluation 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).Clinical evaluation 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%
- Secondary Outcome Measures
Name Time Method Specific parameter interleukin-17 (IL-17) measurement 4 weeks 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 instructionsSpecific parameters (interleukin-1 beta ) (IL-1β)measurement 4 weeks 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.Specific parameter C-reactive protein (CRP) measurement 4 weeks 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