Effect of Vitamin D Injection on Hypertrophic Scars and Keloids

Mostafa Bahaa

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dermatologic Disease

Treatments: Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT06301178

12548

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

vitamin D deficiency

Active Comparator group

Description:

patients with vitamin D deficiency or insufficiency (\<12 ng/ml and 12-19 ng/ml, respectively) received systemic and intralesional vitamin D injections

Treatment:

Drug: Cholecalciferol

vitamin D sufficiency

Active Comparator group

Description:

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.

Treatment:

Drug: Cholecalciferol