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Investigating the Safety and Efficacy of Human Umbilical Cord Blood Serum (HUCBS) Microneedle compared to only Microneedling for Acne Scar treatment

Phase 1
Recruiting
Conditions
Acne Scar.
Registration Number
IRCT20221130056672N7
Lead Sponsor
Research Vice President of Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria

Patients with rolling acne scars with different severity (according to the Goodman grading system)
Complete consent of the patient to participate in the plan
Age 18 years and above and less than 50 years.

Exclusion Criteria

Being positive in terms of the following: active inflammatory acne, active herpes labialis, local infections in the treatment area, prone to keloids, malignancy, pregnancy, breastfeeding, taking drugs that can affect bleeding or clotting mechanisms, immunosuppression, use of local and systemic steroids, systemic diseases), high blood pressure, diabetes, heart, kidney and liver diseases)
Using peels 4 weeks before treatment
It should not be done in areas where botulinum injection has been done due to the possibility of microneedle toxin release
Positive history of bleeding or platelet disorder, positive history of major surgery in the last 6 months, presence of any acute facial infection such as herpes, folliculitis. HIV patients, HBsAg or any chronic disease

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The improvement rate of the depth of acne scars and the amount of skin spots and pores. Timepoint: Biometric tests will be done on the first day before the treatment and one month after the treatment. Method of measurement: Visioface.;The thickness and density of the skin. Timepoint: Biometric tests will be done on the first day before the treatment and one month after the treatment. Method of measurement: Sonography.;Elasticity and plasticity of the skin. Timepoint: Biometric tests will be done on the first day before the treatment and one month after the treatment. Method of measurement: Cutometer.
Secondary Outcome Measures
NameTimeMethod
Safety and Efficacy. Timepoint: Safety checks are done before and after each treatment. Method of measurement: Patient history and the examination and diagnosis of the attending physician.
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