Acne Vulgaris
Conditions
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.
Interventions
OTHERManuka honey( MgO 850, UMF+20) loaded nano-formulation
Assessment of the efficacy of manuka-loaded nano-formulation and manuka honey-loaded gel on the improvement of acne vulgaris
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Masking description
The intervention of each group
Intervention model description
Prospective interventional randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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% |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specific 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 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 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 |
Contacts
Primary ContactMaha Khalifa
Backup ContactMaha Khalifa
Outcome results
None listed