Effect of Vitamin D Injection on Hypertrophic Scars and Keloids

Dermatologic Disease Clinical Trial

Official title:

Effect of Vitamin D Injection on Hypertrophic Scars and Keloids

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06301178
• Other study ID #: 12548
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 27, 2024
• Est. completion date: February 20, 2026

Study information

• Verified date: March 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: February 20, 2026
• Est. primary completion date: February 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age from 12 years to 50 years. Patients with hypertrophic scars and keloids

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Dermatologic Disease
• Skin Diseases

Intervention

Drug:
• Cholecalciferol
Vitamin D has various critical regulatory roles, including inflammatory control, cellular proliferation and differentiation, and wound healing regulation.

Locations

Country	Name	City	State
Egypt	faculty of medicine-Fayoum university	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Mostafa Bahaa

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months