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

NCT ID: NCT06175819

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-09-11

Brief Summary

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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

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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.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective interventional randomized clinical trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants
The intervention of each group

Study Groups

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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)

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Assessment of the efficacy of manuka-loaded nano-formulation and manuka honey-loaded gel on the improvement of acne vulgaris

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)

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Assessment of the efficacy of manuka-loaded nano-formulation and manuka honey-loaded gel on the improvement of acne vulgaris

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)

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

Assessment of the efficacy of manuka-loaded nano-formulation and manuka honey-loaded gel on the improvement of acne vulgaris

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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Manuka honey ( MgO 850, UMF+20)loaded gel

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Maha khalifa

Associate Professor, Pharmaceutics Department, Al-Azhar University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maha Khalifa

Role: STUDY_DIRECTOR

Associate professor of pharmaceutics

Central Contacts

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Maha Khalifa

Role: CONTACT

Phone: +966561148759

Email: [email protected]

Maha Khalifa

Role: CONTACT

Phone: +966561148759

Email: [email protected]

Other Identifiers

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Manuka honey nanoformulation

Identifier Type: -

Identifier Source: org_study_id