VitiligoNCT07267273
Betamethasone Phonophoresis For Vitiligo
A study testing Beclomethasone in people with Vitiligo, run by Cairo University at 1 site in Egypt.
Trial summary
Vitiligo is a skin disorder that results in the formation of depigmented patches or hypopigmented macules due to selective destruction or reduction of melanocytes the cells that produce pigment in our skin. Vitiligo affects 0.1-2% of the World's population. People of all skin types and all ages can be affecte. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Beclomethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2025to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients diagnosed with vitiligo.
- Medically and psychologically stable patients.
- Good cognitive abilities to understand the requirements of the study.
- All patients enrolled to the study will have their informed consent.
- they had no contraindications to the use of therapeutic ultrasound
Who cannot join
- Pregnancy or lactation.
- Immunosuppression.
- Alcohol abuse.
- History of spontaneous re-pigmentation of lesions.
- Presence of skin characteristics that may interfere with study assessment.
- Active bacterial/viral infection.
Show all 9Show fewer
- Patients on other immune suppressants and phototherapy
- Patients currently participating in any other clinical study
- Uncooperative patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University Hospital
Cairo
Khadra Mohamed Ali, Lecturer, +201221954363, Khadra.mohamed63@yahoo.com
Ayman El-sayed Ahmed Yousef, Professor, +201008670653, Dr.ayman2134@gmail.com
About this study
Official title: Effect of Betamethasone Phonophoresis in Treatment of Vitiligo
Vitiligo is a skin disorder that results in the formation of depigmented patches or hypopigmented macules due to selective destruction or reduction of melanocytes the cells that produce pigment in our skin.
Vitiligo affects 0.1-2% of the World's population. People of all skin types and all ages can be affecte. In most of the cases, white patches develop or expand slowly overtime, and in some cases it never progress and remains stable . Vitiligo can be segmental or non-segmental depending upon the morphology of the clinical involvement. It can also be classified as stable or unstable based on the activity of disease.
Read more
Steroids act as anti-inflammatory and immunosuppressant agents. Even if different classes of steroids are now available, the mid- potent ones (e.g. betamethasone dipropionate 0.05% cream, 0.05% clobetasol propionate ointment) are usually preferred for the treatment of young patients .
Now days, topical corticosteroids are the most commonly prescribed agents in treatment of dermatologic conditions .Almost all treatments of vitiligo have borrowed from therapies whose prime targets have been another disease.
Read the detailed description
Many theories have been put forward to explain the pathogenesis of vitiligo and mechanisms that leads to the loss of functional melanocytes from the epidermis. The important ones include a genetic predisposition, autoimmune destruction of melanocytes, altered redox status and free radical mediated melanocyte damage, heightened sympathetic response and catecholamines/neurotransmitter mediated melanocyte damage, and impaired melanocyte adhesion or melanocytorrhagy.Mode of therapy is based on decreasing the activity, thereby achieving stability and later inducing pigmentation.
Vitiligo is classified into Segmental Vitiligo, Non-Segmental Vitiligo and Unclassified according to Vitiligo Global Issues Consensus Conference.Segmental vitiligo lesions are characterized by generally one and less commonly two or multiple segments. Most common form is Uni-segmental form which consists of one or more macules particularly on one side of the body with the involvement of body hair with early age of onset, and rapid stabilization while non-segmental vitiligo lesions are distributed bilaterally in an acrofacial pattern (i.e. affecting the face, hands or feet) or scattered symmetrically over the entire body .
Non-segmental vitiligo (NVS) comprises of acrofacial, generalized, universal, mixed forms. NVS can initially have an acrofacial distribution, which can later progress to the generalized or universal form. Acrofacial vitiligo can affect face, hands and feet and generally involve the perioral region and tips of the fingers. In a study of latent class analyses, two types of non-segmental vitiligo have been identified; the first is of early onset (i.e. before the 12 years of age) and generally associated with halo naevus with premature greying of hair, while second type is of late onset and is mostly associated with an acrofacial pattern. In generalized vitiligo, patient had a few acrofacial lesions for 10 years that evolved within 6 months into generalized form, spreading to the trunk. Universal Vitiligo affects about 80-90% of body surface area and is the most common form of vitiligo.
Generalized vitiligo usually precedes Universal vitiligo. Mixed vitiligo is defined as the combined involvement of both segmental and non-segmental vitiligo in one patient. Generally segmental vitiligo precedes the non-segmental vitiligo. Rare class is also considered as Un-classified type and consists of Follicular Vitiligo, Vitiligo Punctate and Vitiligo Minor. Vitiligo minor is likely to be limited to dark skinned individuals. The term minor here refers to incomplete pigmentation with pale skin compared with healthy skin .
The presence of focal lesions (i.e., small isolated white macule) with no segmental distribution that have not evolved into non-segmental or segmental vitiligo after 1-2 years but can evolve to segmental vitiligo or non-segmental vitiligo is regarded as unclassifiable vitiligo .
In many instances, the first line therapy for vitiligo is topical medicaments. Regarding topical therapy that might be effective in treatment of vitiligo, topical corticosteroids are the usual first line treatment .
The ease of application, high rate of compliance, and low cost are the advantages of topical corticosteroid therapy for vitiligo .Several stronger corticosteroids are now available since their first introduction. They are used as monotherapy or in combination with other agents for increasing efficacy.Topical corticosteroids have been indicated and used during the last three decades for treatment of limited area of vitiligo.
Phonophoresis (PH) is the process of increasing skin absorption and penetration of the topical medications to the deep tissues using US. Topically applied drugs therapeutic effects depend on different factors such as rate, amount, drug penetration dept of the skin and the potential drug toxicological hazards on the tissues
Phonophoresis, also known as sonophoresis, has been claimed to enhance the percutaneous absorption of certain pharmacological agents such as anti- inflammatory steroids and local anesthetics from intact skin into the underlying subcutaneous structures by ultrasound, therefore improving their effectiveness. This procedure is commonly used in physical therapy practices. The procedure generally utilizes an ultrasound apparatus that generates frequencies of 0.7 to 1.1 MHz . The ultrasound intensities employed usually range from 0.0 to 3.0 Watts per cm2. Both continuous-mode as well as pulse-mode applications were utilized, and most treatments lasted from 5 to 8 mins, with the exception of treatments of larger areas (greater than 36 cm2) requiring more than 8 mins.
- Conditions
- Vitiligo
- Being tested
- Beclomethasone
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeclomethasoneDrug
Also called phonophoresis
to determine the effect of betamethasone phonophoresis on vitiligo patients.
| Study group | Role | What they receive |
|---|---|---|
| Patients Group | Active comparator | This group of patients composed of 30 Male and female patients who received betamethasone cream then after 20 minutes ultrasound was applied, three times per week for 1 month. Receives: Drug: Beclomethasone |
| Control Group | Active comparator | This group of patients composed of 30 Male and female patients who received ultrasound then after 20 minutes patients received betamethasone cream, three times per week for 1 month. Receives: Drug: Beclomethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
vitiligo Management
Evaluation of the patients whom suffering from vitiligo and using betamethasone phonophoresis for the treatment of vitiligo using Vitiligo noticeability scale (VNC)
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start10 Nov 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion10 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola sabry Abd-Elmaksoud tarabya, Cairo University
- Investigators
- Nisreen Afify Abd-Elrasheed, Professor, Study chair, Physical Therapy for Surgery,Faculty of Physical Therapy,Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267273
- Sponsor's protocol ID
- Treatment of Vitiligo
- Status last verified
- Nov 2025
- First submitted
- 23 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD sharing as participants request
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
- Effect of Betamethasone Phonophoresis in Treatment of Vitiligo
- ClinicalTrials.gov ID
- NCT07267273
- Acronym / sponsor ID
- Treatment of Vitiligo
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 5 Dec 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.
Vitiligo is a skin disorder that results in the formation of depigmented patches or hypopigmented macules due to selective destruction or reduction of melanocytes the cells that produce pigment in our skin.
Vitiligo affects 0.1-2% of the World's population. People of all skin types and all ages can be affecte. In most of the cases, white patches develop or expand slowly overtime, and in some cases it never progress and remains stable . Vitiligo can be segmental or non-segmental depending upon the morphology of the clinical involvement. It can also be classified as stable or unstable based on the activity of disease.
Steroids act as anti-inflammatory and immunosuppressant agents. Even if different classes of steroids are now available, the mid- potent ones (e.g. betamethasone dipropionate 0.05% cream, 0.05% clobetasol propionate ointment) are usually preferred for the treatment of young patients .
Now days, topical corticosteroids are the most commonly prescribed agents in treatment of dermatologic conditions .Almost all treatments of vitiligo have borrowed from therapies whose prime targets have been another disease.
Detailed description
Many theories have been put forward to explain the pathogenesis of vitiligo and mechanisms that leads to the loss of functional melanocytes from the epidermis. The important ones include a genetic predisposition, autoimmune destruction of melanocytes, altered redox status and free radical mediated melanocyte damage, heightened sympathetic response and catecholamines/neurotransmitter mediated melanocyte damage, and impaired melanocyte adhesion or melanocytorrhagy.Mode of therapy is based on decreasing the activity, thereby achieving stability and later inducing pigmentation.
Vitiligo is classified into Segmental Vitiligo, Non-Segmental Vitiligo and Unclassified according to Vitiligo Global Issues Consensus Conference.Segmental vitiligo lesions are characterized by generally one and less commonly two or multiple segments. Most common form is Uni-segmental form which consists of one or more macules particularly on one side of the body with the involvement of body hair with early age of onset, and rapid stabilization while non-segmental vitiligo lesions are distributed bilaterally in an acrofacial pattern (i.e. affecting the face, hands or feet) or scattered symmetrically over the entire body .
Non-segmental vitiligo (NVS) comprises of acrofacial, generalized, universal, mixed forms. NVS can initially have an acrofacial distribution, which can later progress to the generalized or universal form. Acrofacial vitiligo can affect face, hands and feet and generally involve the perioral region and tips of the fingers. In a study of latent class analyses, two types of non-segmental vitiligo have been identified; the first is of early onset (i.e. before the 12 years of age) and generally associated with halo naevus with premature greying of hair, while second type is of late onset and is mostly associated with an acrofacial pattern. In generalized vitiligo, patient had a few acrofacial lesions for 10 years that evolved within 6 months into generalized form, spreading to the trunk. Universal Vitiligo affects about 80-90% of body surface area and is the most common form of vitiligo.
Generalized vitiligo usually precedes Universal vitiligo. Mixed vitiligo is defined as the combined involvement of both segmental and non-segmental vitiligo in one patient. Generally segmental vitiligo precedes the non-segmental vitiligo. Rare class is also considered as Un-classified type and consists of Follicular Vitiligo, Vitiligo Punctate and Vitiligo Minor. Vitiligo minor is likely to be limited to dark skinned individuals. The term minor here refers to incomplete pigmentation with pale skin compared with healthy skin .
The presence of focal lesions (i.e., small isolated white macule) with no segmental distribution that have not evolved into non-segmental or segmental vitiligo after 1-2 years but can evolve to segmental vitiligo or non-segmental vitiligo is regarded as unclassifiable vitiligo .
In many instances, the first line therapy for vitiligo is topical medicaments. Regarding topical therapy that might be effective in treatment of vitiligo, topical corticosteroids are the usual first line treatment .
The ease of application, high rate of compliance, and low cost are the advantages of topical corticosteroid therapy for vitiligo .Several stronger corticosteroids are now available since their first introduction. They are used as monotherapy or in combination with other agents for increasing efficacy.Topical corticosteroids have been indicated and used during the last three decades for treatment of limited area of vitiligo.
Phonophoresis (PH) is the process of increasing skin absorption and penetration of the topical medications to the deep tissues using US. Topically applied drugs therapeutic effects depend on different factors such as rate, amount, drug penetration dept of the skin and the potential drug toxicological hazards on the tissues
Phonophoresis, also known as sonophoresis, has been claimed to enhance the percutaneous absorption of certain pharmacological agents such as anti- inflammatory steroids and local anesthetics from intact skin into the underlying subcutaneous structures by ultrasound, therefore improving their effectiveness. This procedure is commonly used in physical therapy practices. The procedure generally utilizes an ultrasound apparatus that generates frequencies of 0.7 to 1.1 MHz . The ultrasound intensities employed usually range from 0.0 to 3.0 Watts per cm2. Both continuous-mode as well as pulse-mode applications were utilized, and most treatments lasted from 5 to 8 mins, with the exception of treatments of larger areas (greater than 36 cm2) requiring more than 8 mins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients Group | Active comparator | Drug: BeclomethasoneThis group of patients composed of 30 Male and female patients who received betamethasone cream then after 20 minutes ultrasound was applied, three times per week for 1 month. |
| Control Group | Active comparator | Drug: BeclomethasoneThis group of patients composed of 30 Male and female patients who received ultrasound then after 20 minutes patients received betamethasone cream, three times per week for 1 month. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female patients diagnosed with vitiligo.
- Medically and psychologically stable patients.
- Good cognitive abilities to understand the requirements of the study.
- All patients enrolled to the study will have their informed consent.
- they had no contraindications to the use of therapeutic ultrasound
Key exclusion criteria (9 listed)
- Pregnancy or lactation.
- Immunosuppression.
- Alcohol abuse.
- History of spontaneous re-pigmentation of lesions.
- Presence of skin characteristics that may interfere with study assessment.
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 |
|---|---|---|
| BeclomethasoneAlso: phonophoresisto determine the effect of betamethasone phonophoresis on vitiligo patients. | Drug | Control Group, Patients Group |
Primary outcome
vitiligo Management
Time frame: 3 Months
Evaluation of the patients whom suffering from vitiligo and using betamethasone phonophoresis for the treatment of vitiligo using Vitiligo noticeability scale (VNC)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No. No IPD sharing as participants request
Related trials for Vitiligo
RecruitingPhase 2
A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
Non-Segmental Vitiligo (NSV)
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Not yet recruitingPhase 2/3
Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo
Vitiligo
RecruitingPhase 2
A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
Vitiligo, Non-Segmental Vitiligo (NSV)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Nonsegmental Vitiligo
Nonsegmental Vitiligo
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.
Nisreen Afify Abd-Elrasheed, Professor study chair
Physical Therapy for Surgery,Faculty of Physical Therapy,Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beclomethasone in people with Vitiligo, run by Cairo 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 5 inclusion and 9 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ola Sabry Abd-Elmaksoud Tarabya, MSc (+201024035447, Olasabry17@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vitiligo Management (time frame: 3 Months). 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.