Scar, HypertrophicPhase 3NCT06729840
Intralesional Treatment of Keloids
A Phase 3 study testing Injection in people with Scar, Hypertrophic, run by Sohag University at 1 site in Egypt.
Trial summary
Intralesional injection in treatment of keloid Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Scar, Hypertrophic
- What is being tested?
- Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 2 May 2025
- Phase
- Phase 3
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both sex aged 18-60 having keloid
- -
Who cannot join
- pregnancy , lactation Skin disease
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
Sohag university hospital
Sohag
Sama alaa, Master, 01027748791, Samaalaa.867@gmail.com
About this study
Official title: Vitamin D in Keloids
Intralesional injection in treatment of keloid
Read the detailed description
Our study will include 45 patient diveded into three groups , follow up will done before each session , 3month after the last session using photographing assessment , scoring , dermoscope
- Conditions
- Scar, Hypertrophic
- Being tested
- Injection
- Keywords
- keloids , vitamin D
- Medical subject headings
- Cicatrix, Hypertrophic, Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InjectionDrug
Vitamin D , botox , tramcinolone intralesionally injected in keloid
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Will include 15 patients will injected with vitamin D Receives: Drug: Injection |
| Group 2 | Active comparator | Will include 15 patients will injected with botulinum toxin type A Receives: Drug: Injection |
| Group 3 | Active comparator | Will include 15 patients will injected with triamcinolone acetonide Receives: Drug: Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posas score
patient and observer parameters will be assessed
Measured: One session every two weeks total duration 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion2 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scar, HypertrophicStudies of the same condition, open and under way.
- More trials run by Sohag 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sama Alaaeldin Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729840
- Sponsor's protocol ID
- Soh-Med--24-11-05MS
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D in Keloids
- ClinicalTrials.gov ID
- NCT06729840
- Acronym / sponsor ID
- Soh-Med--24-11-05MS
- Conditions
- Scar, Hypertrophic
- Keywords
- keloids , vitamin D
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 2 May 2025 (estimated)
- First posted
- 11 Dec 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.
Intralesional injection in treatment of keloid
Detailed description
Our study will include 45 patient diveded into three groups , follow up will done before each session , 3month after the last session using photographing assessment , scoring , dermoscope
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 3 groups
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: InjectionWill include 15 patients will injected with vitamin D |
| Group 2 | Active comparator | Drug: InjectionWill include 15 patients will injected with botulinum toxin type A |
| Group 3 | Active comparator | Drug: InjectionWill include 15 patients will injected with triamcinolone acetonide |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Both sex aged 18-60 having keloid
- -
Key exclusion criteria (1 listed)
- pregnancy , lactation Skin disease
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 |
|---|---|---|
| InjectionVitamin D , botox , tramcinolone intralesionally injected in keloid | Drug | Group 1, Group 2, Group 3 |
Primary outcome
Posas score
Time frame: One session every two weeks total duration 3 months
patient and observer parameters will be assessed
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 11 Dec 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Injection in people with Scar, Hypertrophic, run by Sohag 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 2 inclusion and 1 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 11 Dec 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 sama alaa, resident doctor (01027748791, samaalaa.867@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posas score (time frame: One session every two weeks total duration 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 11 Dec 2024.