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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06301178
Other study ID # 12548
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
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