Cicatrix Clinical Trial
Official title:
A Phase II, Randomized, Placebo-Controlled Study of the Long-term Efficacy of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars
Verified date | December 2022 |
Source | Maternal and Child Health Hospital of Foshan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is to investigate the long-term efficacy of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 1, 2022 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 21 Years to 35 Years |
Eligibility | Inclusion Criteria: - Primiparous women receiving cesarean delivery - Ages between 21-35 years - Gestation ages = 37 weeks and < 42 weeks - Willing to give and sign an informed consent form and a photographic release form - Willing to comply with study dosing and complete the entire course of the study Exclusion Criteria: - Any systemic uncontrolled disease - Recent or current cancer - History or presenting with a keloid formation - Wounds or local disease in treatment area - Planning any other cosmetic procedure to the study area during the study period - Smoking |
Country | Name | City | State |
---|---|---|---|
China | Maternal and Child Health Hospital of Foshan | Foshan | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Maternal and Child Health Hospital of Foshan |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vancouver Scar Scale score | The investigators measured scar at three years post treatment using Vancouver Scar Scale (VSS). The VSS included vascularity (normal, pink, red, or purple), pigmentation (normal, hypopigmented, mixed, or hyperpigmented), height (flat, < 2 mm, 2-5 mm, or > 5 mm), and pliability (normal, supple, yielding, firm, ropes, or contracture). Each variable contained ranked subscales that could be summed to obtain a total score ranging from 0 to 14, with 0 representing normal skin and a higher score representing a more marked or abnormal scar. The Chinese version of the VSS has been shown to have good intraclass correlations and Cronbach's a measures. All scars will be assessed independently by two observers on the same day when the participants are lying in a supine position with the scar exposed in bright light. If the data varies, another researcher will be required to assess the scar at the same day and the results with the highest frequency will be recorded. | Three years post treatment | |
Secondary | Erythema | measured by reflectance | Three years post treatment | |
Secondary | Pigmentation | measured by reflectance | Three years post treatment | |
Secondary | Scar Thickness and Uniformity | A High Definition Ultrasound (US) device will be used to generate a high resolution image of the skin layers of the treated and non-treated scar in order to measure and compare changes in scar thickness and uniformity. | Three years post treatment | |
Secondary | Subject's satisfaction | Subject's satisfaction of the treatment using a Satisfaction Scale as follows: None; Slight; Moderate; Good; Very Good. | Three years post treatment |
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