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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acne Vulgaris
• Intervention / Treatment: Other: Manuka honey( MgO 850, UMF+20) loaded nano-formulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maha Khalifa; Phone Number: +966561148759; Email: Mahakhalifa.pharmg@azhar.edu.eg
• Study Contact Backup: Name: Maha Khalifa; Phone Number: +966561148759; Email: Mahakhalifa.ahmed@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manuka nanoformulation group; 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)	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; Other Names: Manuka honey ( MgO 850, UMF+20)loaded gel
Experimental: Manuka honey gel group; 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)	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; Other Names: Manuka honey ( MgO 850, UMF+20)loaded gel
Active Comparator: clindamycin commercial gel; 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)	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; Other Names: Manuka honey ( MgO 850, UMF+20)loaded gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Director: Maha Khalifa, Associate professor of pharmaceutics

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): April 11, 2024
• Study Completion (Estimated): September 11, 2024

Study Registration Dates

• First Submitted: November 19, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Estimated): December 19, 2023

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: Manuka honey nanoformulation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No