Clinical Insights Into Dextrose Phonophoresis on Mild to Moderate Acne Vulgaris

NCT07169890 | Completed

• 1 other identifier: P.T.REC/012/005946
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (3)

• Acne Global Severity Scale (AGSS):

  The Acne Global Severity Scale is a qualitative tool used to evaluate the overall severity of a patient's acne.Based on the examination, acne severity is classified into a standardized scale:((0: Clear skin with no inflammatory or non-inflammatory lesions,1: Almost clear with rare non-inflammatory lesions and no more than one small inflammatory lesion,2: Mild presence of non-inflammatory lesions with few inflammatory lesions,3: Moderate presence of numerous non-inflammatory lesions and several inflammatory lesions,4: Severe presence of many non-inflammatory and inflammatory lesions, including nodules).0-1: Represents mild or no acne; often considered within normal limits.2-4: Indicates increasing severity needing clinical intervention.

  at baseline and at 4 weeks

• Acne Severity Index (ASI):

  The Acne Severity Index is a quantitative measure that combines lesion counts and types to produce a single score.Score Calculation: Use the following formula to calculate the ASI :(( ASI = (Number of Comedones) + (2 × Number of Papules) + (3 × Number of Pustules) + (4 × Number of Nodules)).Scores can vary significantly; typically, lower scores (\<10) indicate mild acne, while higher scores (20+) suggest moderate to severe acne.

  at baseline and at 4 weeks

• Total Lesion Count (TLC)

  Total Lesion Count is a straightforward quantitative assessment: Counting: Count all types of acne lesions (comedones, papules, pustules, nodules) on the face, chest, and back.(0-10 lesions: Considered mild,11-25 lesions: Moderate severity,26+ lesions: Severe acne requiring intervention).

  at baseline and at 4 weeks

Study Arms (4)

Dextrose Phonophoresis

EXPERIMENTAL

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

Other: Dextrose Phonophoresis

Ultrasound

EXPERIMENTAL

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.

Other: Ultrasound

Dextrose topical gel

EXPERIMENTAL

Topical application of dextrose gel

Other: Dextrose Topical application

Control group

NO INTERVENTION

No intervention

Interventions

Ultrasound OTHER

the ultrasound probe is moved in a circular motion over the skin for a duration of 5 to 10 minutes per session

Ultrasound

Dextrose Topical application OTHER

Apply a thin layer of the dextrose gel evenly across the acne-affected areas using a sterile applicator or cotton pad

Dextrose topical gel

Dextrose Phonophoresis OTHER

To apply Dextrose Phonophoresis on a patient with acne vulgaris, begin by cleansing the affected skin area thoroughly with a gentle, non-comedogenic cleanser to remove any dirt or oils. Pat the skin dry with a clean towel. Prepare a dextrose gel, a 10% dextrose gel, which is then coupled with low-frequency ultrasound to facilitate deeper penetration of the dextrose

Dextrose Phonophoresis

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MTI University: lead

Study Sites (1)

faculty of physical therapy ,Cairo University

Cairo, 11311, Egypt

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant professor

Model Details: RCT

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start: November 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

EG (1)