Effect of Vitamin D Injection on Hypertrophic Scars and Keloids

NCT06301178 | Completed Phase 1

• 1 other identifier: 12548
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dermatologic Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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.

Drug: Cholecalciferol

Interventions

Cholecalciferol DRUG

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

vitamin D deficiency; vitamin D sufficiency

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mostafa Bahaa: lead

Study Sites (1)

faculty of medicine-Fayoum university

Al Fayyum, 63519, Egypt

Location

Related Publications (1)

• 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.

  PMID: 40135774 DERIVED

MeSH Terms

Conditions

Skin Diseases

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Teaching assisstant

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 8, 2024
• Study Start: February 27, 2024
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

EG (1)