Localized SclerodermaNCT06621628
Photobiomodulation in Children With Localized Scleroderma
A study testing Study Group A, Study GrouB and Study Group C in people with Localized Scleroderma, run by New Ismailia National University at 2 sites in Egypt.
Trial summary
to evaluate the efficacy of the Polarized light therapy and Hand Grip Strengthening exercises in patients with CREST syndrome Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Localized Scleroderma
- What is being tested?
- Study Group A, Study GrouB and Study Group C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Apr 2025to 5 Nov 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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The patients' ages ranged from 8 to 11 years.
- Patients who had hand involvement of patients with localized scleroderma, particularly dorsum of the hand.
- All patients were conscious.
- All patients were randomly chosen (male and female).
Who cannot join
- Patients who are diabetic or hypertensive.
- Patients those familiar with the BLT and resisted exercise via the hand grip strengthener.
- Patients with hemorrhage specially hemorrhage of digestive system and those with bleeding per rectum.
- Patients with severe fungal diseases and acute viral diseases.
- Patients with active tuberculosis and tumors as well as those with peacemakers.
- Patients with thyroid problems
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Khadra Mohamed Ali
Ismailia, 8332601
Mohamed Abdel Moenem Abo El Ros
Ismailia, 8332601
About this study
Official title: The Effectiveness of Photo-biomodulation and Hand Grip Strengthening on Children With Localized Scleroderma in the Egyptian Population : A Randomized Clinical Trial
to evaluate the efficacy of the Polarized light therapy and Hand Grip Strengthening exercises in patients with CREST syndrome
Read the detailed description
Measurement of the skin thickness via the modified Rodnon skin score (RSS) and Hand Grip Dynamometer (HGD) . Methods:- Sixty patients, who had hand involvement of children with localized scleroderma, were participated in the study. Their ages were ranged from 8 to 11 years. The participants were selected from the dermatology departments of Cairo university hospitals and Om El-Misrieen hospital, randomly distributed into three equal groups. Group A: (Study group): This group included 7 patients who had localized scleroderma in the dorsum of hands and who received the BLT with traditional physical therapy program (stretching, strengthening and active exercise) patients received 3 sessions per week for 12 weeks (3 months),time of session is 15 minutes. Group B: This group included 7 patients who have localized scleroderma in the dorsum of hands and who received resisted exercise with traditional physical therapy program (stretching, strengthening and active exercise) patients received 3 sessions per week for 12 weeks (3 months), time of session is 15 minutes and Group C:This group included 7 patients who had localized scleroderma in the dorsum of hands and who received combination of (BLT and resisted exercise) with traditional physical therapy program (stretching, strengthening and active exercise) exercise program (stretching, strengthening and active exercise).Patients received 3 sessions per week for 12weeks (3 months), the time of each session was 15 minutes.
- Conditions
- Localized Scleroderma
- Being tested
- Study Group A, Study GrouB, Study Group C
- Keywords
- Polarized light therapy, Resisted exercise, localized scleroderma, Modified Rodnon skin score, and Hand Grip Dynamometer
- Medical subject headings
- Scleroderma, Localized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Group AOther
resisted exercise
Study GrouBDevice
Bioptron light therapy device, resisted exercises and stretching exercises
Study Group COther
, stretching and active range of motion hand exercises
| Study group | Role | What they receive |
|---|---|---|
| Study group A | Experimental | This group included 7 patients who had localized scleroderma in the dorsum of hands and who received the photobiomodulaion with traditional physical therapy program (stretching, strengthening and active exercise) patients received 3 sessions per week for 12 weeks (3 months),time of session is 15 minutes. Receives: Other: Study Group A |
| study group B | Experimental | This group included 7 patients who have localized scleroderma in the dorsum of hands and who received resisted exercise with traditional physical therapy program (stretching, strengthening and active exercise) patients received 3 sessions per week for 12 weeks (3 months), time of session is 15 minutes Receives: Device: Study GrouB |
| study group C | Experimental | This group included 7 patients who had localized scleroderma in the dorsum of hands and who received combination of (bipotron light therapy and resisted exercise) with traditional physical therapy program (stretching, strengthening and active exercise) exercise program (stretching, strengthening and active exercise).patients received 3 sessions per week for 12weeks (3 months), time of session is 15 minutes Receives: Other: Study Group C |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin thickness
modified random skin score
Measured: 12 weeks
hand grip strength and pinch gauge
Hand dynamometer
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start10 Apr 2025
- Primary completion1 Jul 2025
- Study completion5 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized SclerodermaStudies 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
- to evaluate the efficacy of the Polarized light therapy and Hand Grip Strengthening exercises in patients with CREST syndrome.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Ismailia National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdel Moeim Abo EL Ros, New Ismailia National University
- Investigators
- Zakaria E Mowafy, Ph.D, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621628
- Sponsor's protocol ID
- REC/2111/MTI.PT/2511402
- Status last verified
- Apr 2026
- First submitted
- 26 Sep 2024
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: this proposal was assigned to evaluate skin thickness and pinch gauge concerning hand function using Bioptron light therapy in patients with crest syndrome
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Photo-biomodulation and Hand Grip Strengthening on Children With Localized Scleroderma in the Egyptian Population : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06621628
- Acronym / sponsor ID
- REC/2111/MTI.PT/2511402
- Conditions
- Localized Scleroderma
- Keywords
- Polarized light therapy, Resisted exercise, localized scleroderma, Modified Rodnon skin score, and Hand Grip Dynamometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- New Ismailia National UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 1 Oct 2024 (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.
to evaluate the efficacy of the Polarized light therapy and Hand Grip Strengthening exercises in patients with CREST syndrome
Detailed description
Measurement of the skin thickness via the modified Rodnon skin score (RSS) and Hand Grip Dynamometer (HGD) . Methods:- Sixty patients, who had hand involvement of children with localized scleroderma, were participated in the study. Their ages were ranged from 8 to 11 years. The participants were selected from the dermatology departments of Cairo university hospitals and Om El-Misrieen hospital, randomly distributed into three equal groups. Group A: (Study group): This group included 7 patients who had localized scleroderma in the dorsum of hands and who received the BLT with traditional physical therapy program (stretching, strengthening and active exercise) patients received 3 sessions per week for 12 weeks (3 months),time of session is 15 minutes. Group B: This group included 7 patients who have localized scleroderma in the dorsum of hands and who received resisted exercise with traditional physical therapy program (stretching, strengthening and active exercise) patients received 3 sessions per week for 12 weeks (3 months), time of session is 15 minutes and Group C:This group included 7 patients who had localized scleroderma in the dorsum of hands and who received combination of (BLT and resisted exercise) with traditional physical therapy program (stretching, strengthening and active exercise) exercise program (stretching, strengthening and active exercise).Patients received 3 sessions per week for 12weeks (3 months), the time of each session was 15 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- to evaluate the efficacy of the Polarized light therapy and Hand Grip Strengthening exercises in patients with CREST syndrome.
| Arm | Type | Receives |
|---|---|---|
| Study group A | Experimental | Other: Study Group AThis group included 7 patients who had localized scleroderma in the dorsum of hands and who received the photobiomodulaion with traditional physical therapy program (stretching, strengthening and active exercise) patients received 3 sessions per week for 12 weeks (3 months),time of session is 15 minutes. |
| study group B | Experimental | Device: Study GrouBThis group included 7 patients who have localized scleroderma in the dorsum of hands and who received resisted exercise with traditional physical therapy program (stretching, strengthening and active exercise) patients received 3 sessions per week for 12 weeks (3 months), time of session is 15 minutes |
| study group C | Experimental | Other: Study Group CThis group included 7 patients who had localized scleroderma in the dorsum of hands and who received combination of (bipotron light therapy and resisted exercise) with traditional physical therapy program (stretching, strengthening and active exercise) exercise program (stretching, strengthening and active exercise).patients received 3 sessions per week for 12weeks (3 months), time of session is 15 minutes |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The patients' ages ranged from 8 to 11 years.
- Patients who had hand involvement of patients with localized scleroderma, particularly dorsum of the hand.
- All patients were conscious.
- All patients were randomly chosen (male and female).
Key exclusion criteria (6 listed)
- Patients who are diabetic or hypertensive.
- Patients those familiar with the BLT and resisted exercise via the hand grip strengthener.
- Patients with hemorrhage specially hemorrhage of digestive system and those with bleeding per rectum.
- Patients with severe fungal diseases and acute viral diseases.
- Patients with active tuberculosis and tumors as well as those with peacemakers.
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 |
|---|---|---|
| Study Group Aresisted exercise | Other | Study group A |
| Study GrouBBioptron light therapy device, resisted exercises and stretching exercises | Device | study group B |
| Study Group C, stretching and active range of motion hand exercises | Other | study group C |
Primary outcome
skin thickness
Time frame: 12 weeks
modified random skin score
hand grip strength and pinch gauge
Time frame: 12 weeks
Hand dynamometer
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 17 Apr 2026.
- Individual participant dataSharing planned: No. this proposal was assigned to evaluate skin thickness and pinch gauge concerning hand function using Bioptron light therapy in patients with crest syndrome
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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.
Zakaria E Mowafy, Ph.D study director
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Group A, Study GrouB and Study Group C in people with Localized Scleroderma, run by New Ismailia National University at 2 sites 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 6 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 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
skin thickness (time frame: 12 weeks). The study lists 2 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 17 Apr 2026.