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

Al-Azhar University

Status: Not yet enrolling

Conditions: Acne Vulgaris

Treatments: Other: Manuka honey( MgO 850, UMF+20) loaded nano-formulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06175819

Manuka honey nanoformulation

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 3 patient groups

Manuka nanoformulation group

Experimental group

Description:

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)

Treatment:

Other: Manuka honey( MgO 850, UMF+20) loaded nano-formulation

Manuka honey gel group

Experimental group

Description:

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)

Treatment:

Other: Manuka honey( MgO 850, UMF+20) loaded nano-formulation

clindamycin commercial gel

Active Comparator group

Description:

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)

Treatment:

Other: Manuka honey( MgO 850, UMF+20) loaded nano-formulation