Clinical Insights Into Dextrose Phonophoresis on Mild to Moderate Acne Vulgaris

MTI University

Status: Completed

Conditions: Acne Vulgaris

Treatments: Other: Dextrose Topical application; Other: Dextrose Phonophoresis; Other: Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT07169890

P.T.REC/012/005946

Details and patient eligibility

About

Acne vulgaris is a common cutaneous inflammatory disorder of the pilosebaceous unit, which runs a chronic course. The condition commonly manifests with papules, pustules, or nodules primarily on the face, although it can also affect the upper arms, trunk, and back. The pathogenesis of acne vulgaris involves the interaction of multiple factors that ultimately lead to the formation of its primary lesion, which is known as "comedo" (see Image. Acne Vulgaris). Although acne vulgaris is commonly observed among adolescents, it is not restricted to this age group and can affect individuals of various ages. The severity of this condition can vary, ranging from a mild presentation with only a few comedones to more severe forms characterized by disfiguring inflammatory manifestations, which can lead to hyperpigmentation, scarring, and adverse psychological effects.

Full description

Dextrose phonophoresis emerges as a novel therapeutic modality in the management of mild to moderate acne vulgaris, an inflammatory skin condition that affects a significant portion of the adolescent and adult population. The rationale for employing dextrose phonophoresis lies in its dual mechanism of enhancing drug delivery and providing anti-inflammatory effects. Phonophoresis, which involves the use of ultrasound waves to enhance the transdermal delivery of topically applied medications, can potentiate the penetration of dextrose into the skin. Dextrose, a simple sugar, is hypothesized to modulate local inflammation and promote healing. This method leverages the mechanical effects of ultrasound to increase the permeability of the stratum corneum, thereby facilitating deeper penetration of dextrose into the dermal layers where it can exert its therapeutic effects.

The anti-inflammatory properties of dextrose are pivotal in its role in treating acne vulgaris. Acne is characterized by the inflammation of pilosebaceous units, and dextrose is believed to mitigate this inflammation through osmotic and possibly metabolic pathways. By reducing the inflammatory response, dextrose phonophoresis may decrease the erythema and lesion count associated with acne vulgaris.

Enrollment: 115 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals aged 18 to 30 years.
• Clinically diagnosed with mild to moderate acne vulgaris.
• Willingness to comply with the study protocol and attend all treatment sessions.
• Medical Clearance: Participants must have medical clearance to participate in this study.

Exclusion criteria

• Individuals with severe acne vulgaris or other dermatological conditions affecting the face.
• Current use of systemic acne medications or topical treatments other than the study intervention.
• Known allergy to magnesium or ultrasound gel.
• Pregnant or breastfeeding individuals.
• Severe Comorbidities: Individuals with severe cardiovascular, pulmonary, metabolic, or vascular diseases
• Medication Interference: Individuals using medications known to affect presence of acne.
• Acute Psychological Conditions: Participants with acute psychological conditions that may interfere with participation or assessments.
• Obese patient whose BMI ≥ 30.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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115 participants in 4 patient groups

Dextrose Phonophoresis

Experimental group

Description:

An individually prepared and equivalent 4-g dose of 0.33% dexamethasone gel (Vann Healthcare Services Inc, Glasgow, KY) from the same lot was applied. A topical dexamethasone gel applied then ultrasound treatment

Treatment:

Other: Dextrose Phonophoresis

Ultrasound

Experimental group

Description:

Using an ultrasound device set to a frequency of 1 MHz, with an intensity ranging from 0.5 to 1.5 W/cm², the ultrasound probe is moved in a circular motion over the skin for a duration of 5 to 10 minutes per session.

Treatment:

Other: Ultrasound

Dextrose topical gel

Experimental group

Description:

Topical application of dextrose gel

Treatment:

Other: Dextrose Topical application

Control group

No Intervention group

Description:

No intervention