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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06175819
• Other study ID #: Manuka honey nanoformulation
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: September 11, 2024

Study information

• Verified date: December 2023
• Source: Al-Azhar University
• Contact: Maha Khalifa
• Phone: +966561148759
• Email: Mahakhalifa.pharmg[@]azhar.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: September 11, 2024
• Est. primary completion date: April 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Other:
• Manuka 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Specific parameters (interleukin-1 beta ) (IL-1ß)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
Secondary	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
Secondary	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