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

NCT06175819 | Unknown DMC

• 1 other identifier: Manuka honey nanoformulation
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Specific parameters (interleukin-1 beta ) (IL-1β)measurement

  4 weeks

• Specific parameter interleukin-17 (IL-17) measurement

  4 weeks

• Specific parameter C-reactive protein (CRP) measurement

  4 weeks

Study Arms (3)

Manuka nanoformulation group

EXPERIMENTAL

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

Manuka honey gel group

EXPERIMENTAL

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

clindamycin commercial gel

ACTIVE COMPARATOR

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

Interventions

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

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

Also known as: Manuka honey ( MgO 850, UMF+20)loaded gel

Manuka honey gel group; Manuka nanoformulation group; clindamycin commercial gel

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Maha Khalifa

  Associate professor of pharmaceutics

  STUDY DIRECTOR

Central Study Contacts

Maha Khalifa

CONTACT

+966561148759; Mahakhalifa.pharmg@azhar.edu.eg

Maha Khalifa

CONTACT

+966561148759; Mahakhalifa.ahmed@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The intervention of each group
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pharmaceutics Department, Al-Azhar University

Model Details: Prospective interventional randomized clinical trial

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: December 19, 2023
• Study Start: January 1, 2024
• Primary Completion: April 11, 2024
• Study Completion: September 11, 2024
• Last Updated: December 19, 2023

Record last verified: 2023-12