Acne VulgarisNCT07169890
Clinical Insights Into Dextrose Phonophoresis on Mild to Moderate Acne Vulgaris
A study testing Dextrose Phonophoresis, Ultrasound and Dextrose Topical application in people with Acne Vulgaris, run by MTI University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Dextrose Phonophoresis, Ultrasound and Dextrose Topical application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Acne Vulgaris
- Being tested
- Dextrose Phonophoresis, Ultrasound, Dextrose Topical application
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose PhonophoresisOther
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
UltrasoundOther
the ultrasound probe is moved in a circular motion over the skin for a duration of 5 to 10 minutes per session
Dextrose Topical applicationOther
Apply a thin layer of the dextrose gel evenly across the acne-affected areas using a sterile applicator or cotton pad
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Ultrasound |
| Dextrose topical gel | Experimental | Topical application of dextrose gel Receives: Other: Dextrose Topical application |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: at baseline and at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Nov 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169890
- Sponsor's protocol ID
- P.T.REC/012/005946
- Status last verified
- Dec 2025
- First submitted
- 5 Sep 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Insights Into Dextrose Phonophoresis on Mild to Moderate Acne Vulgaris
- ClinicalTrials.gov ID
- NCT07169890
- Acronym / sponsor ID
- P.T.REC/012/005946
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Dextrose Phonophoresis | Experimental | Other: Dextrose PhonophoresisAn 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 |
| Ultrasound | Experimental | Other: UltrasoundUsing 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. |
| Dextrose topical gel | Experimental | Other: Dextrose Topical applicationTopical application of dextrose gel |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextrose PhonophoresisTo 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 | Other | Dextrose Phonophoresis |
| Ultrasoundthe 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 applicationApply a thin layer of the dextrose gel evenly across the acne-affected areas using a sterile applicator or cotton pad | Other | Dextrose topical gel |
Primary outcome
Acne Global Severity Scale (AGSS):
Time frame: at baseline and at 4 weeks
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.
Acne Severity Index (ASI):
Time frame: at baseline and at 4 weeks
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.
Total Lesion Count (TLC)
Time frame: at baseline and at 4 weeks
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dextrose Phonophoresis, Ultrasound and Dextrose Topical application in people with Acne Vulgaris, run by MTI University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acne Global Severity Scale (AGSS): (time frame: at baseline and at 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.