Dermatologic DiseasePhase 1/2NCT06301178
Effect of Vitamin D Injection on Hypertrophic Scars and Keloids
A Phase 1/2 study testing Cholecalciferol in people with Dermatologic Disease, run by Mostafa Bahaa at 1 site in Egypt.
Trial summary
Scars and keloids cause patients severe morbidity and psychological distress. Hypertrophic scars rise above the skin but stay within the scar boundaries, while keloids expand. The development of keloids and hypertrophic scars is a consequence of insufficient wound healing. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dermatologic Disease
- What is being tested?
- Cholecalciferol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Feb 2024to 20 Feb 2025
- Phase
- Phase 1/2
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 12 years to 50 years. Patients with hypertrophic scars and keloids
Who cannot join
- Age below 12 years and above 50 years. Patients received other treatment modalities for hypertrophic scars and keloids.
- Systemic and other skin diseases. Patients were already receiving supplemental vitamin D.
Trial locations and contacts
1 site in 1 country.
About this study
Scars and keloids cause patients severe morbidity and psychological distress. Hypertrophic scars rise above the skin but stay within the scar boundaries, while keloids expand.
The development of keloids and hypertrophic scars is a consequence of insufficient wound healing. These lesions are distinguished by excessive ECM deposition. Excessive ECM deposition is caused by increased inflammatory and proliferative processes and decreased remodeling activities. These scarring lesions are also linked to genetic and systemic causes
- Conditions
- Dermatologic Disease
- Being tested
- Cholecalciferol
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Vitamin D has various critical regulatory roles, including inflammatory control, cellular proliferation and differentiation, and wound healing regulation.
| Study group | Role | What they receive |
|---|---|---|
| vitamin D deficiency | Active comparator | patients with vitamin D deficiency or insufficiency (<12 ng/ml and 12-19 ng/ml, respectively) received systemic and intralesional vitamin D injections Receives: Drug: Cholecalciferol |
| vitamin D sufficiency | Active comparator | Patients with vitamin D sufficiency (20 and greater ng/mL) of vitamin D received only intralesional injections of vitamin D on hypertrophic scars and keloids. Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical scoring by Vancouver Scale Score
Four characteristics of the scar are assessed. These are: vascularity, height, pliability, and pigmentation. Each characteristic is given a score, which are added together to give an overall score between 0 and 13
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 posted8 Mar 2024
- Study start27 Feb 2024
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dermatologic DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mostafa Bahaa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mostafa Bahaa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301178
- Sponsor's protocol ID
- 12548
- Status last verified
- Apr 2025
- First submitted
- 23 Feb 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hassan AR, Binsaleh AY, El-Tahlawi SM, El-Amir AM, Ishak MM, Alsubaie N, El-Masry TA, Bahaa MM, Eldesoqui M, Kamal M. Impact of Vitamin D Injection on Keloids and Hypertrophic Scars. J Cosmet Dermatol. 2025 Apr;24(4):e70118. doi: 10.1111/jocd.70118.
PubMed 40135774
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Injection on Hypertrophic Scars and Keloids
- ClinicalTrials.gov ID
- NCT06301178
- Acronym / sponsor ID
- 12548
- Conditions
- Dermatologic Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mostafa BahaaUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 8 Mar 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.
Scars and keloids cause patients severe morbidity and psychological distress. Hypertrophic scars rise above the skin but stay within the scar boundaries, while keloids expand.
The development of keloids and hypertrophic scars is a consequence of insufficient wound healing. These lesions are distinguished by excessive ECM deposition. Excessive ECM deposition is caused by increased inflammatory and proliferative processes and decreased remodeling activities. These scarring lesions are also linked to genetic and systemic causes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D deficiency | Active comparator | Drug: Cholecalciferolpatients with vitamin D deficiency or insufficiency (<12 ng/ml and 12-19 ng/ml, respectively) received systemic and intralesional vitamin D injections |
| vitamin D sufficiency | Active comparator | Drug: CholecalciferolPatients with vitamin D sufficiency (20 and greater ng/mL) of vitamin D received only intralesional injections of vitamin D on hypertrophic scars and keloids. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age from 12 years to 50 years. Patients with hypertrophic scars and keloids
Key exclusion criteria (2 listed)
- Age below 12 years and above 50 years. Patients received other treatment modalities for hypertrophic scars and keloids.
- Systemic and other skin diseases. Patients were already receiving supplemental vitamin D.
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 |
|---|---|---|
| CholecalciferolVitamin D has various critical regulatory roles, including inflammatory control, cellular proliferation and differentiation, and wound healing regulation. | Drug | vitamin D deficiency, vitamin D sufficiency |
Primary outcome
Clinical scoring by Vancouver Scale Score
Time frame: 3 months
Four characteristics of the scar are assessed. These are: vascularity, height, pliability, and pigmentation. Each characteristic is given a score, which are added together to give an overall score between 0 and 13
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 8 Apr 2025.
- Derived from this study: PubMed 40135774Hassan AR, Binsaleh AY, El-Tahlawi SM, El-Amir AM, Ishak MM, Alsubaie N, El-Masry TA, Bahaa MM, Eldesoqui M, Kamal M. Impact of Vitamin D Injection on Keloids and Hypertrophic Scars. J Cosmet Dermatol. 2025 Apr;24(4):e70118. doi: 10.1111/jocd.70118.
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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.
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 Phase 1/2 study testing Cholecalciferol in people with Dermatologic Disease, run by Mostafa Bahaa 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 1 inclusion and 2 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 8 Apr 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical scoring by Vancouver Scale Score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06301178, which also lists 1 linked publication.
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 8 Apr 2025.