Clinical trial NCT06175819: Efficacy of Manuka Honey Nano-Formulation in the Treatment of Acne Vulgaris
Official title: Efficacy of Manuka Honey Nano-Formulatin on the Clinical Improvement and Inflammatory Markers Reduction in Patients With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acne Vulgaris
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective interventional randomized clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical evaluation
timeFrame: 4 weeks
measure: Acne severity evaluation
timeFrame: 4 weeks
Secondary outcomes:
measure: Specific parameters (interleukin-1 beta ) (IL-1β)measurement
timeFrame: 4 weeks
measure: Specific parameter interleukin-17 (IL-17) measurement
timeFrame: 4 weeks
measure: Specific parameter C-reactive protein (CRP) measurement
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Associate professor of pharmaceutics
name: Maha Khalifa
role: STUDY_DIRECTOR
References: