The role of an over the counter topical containing green tea extract in scarring

Not Applicable

Completed

• Conditions: Cosmetic skin scarring; Skin and Connective Tissue Diseases

• Registration Number: ISRCTN18643079
• Lead Sponsor: niversity of Manchester

Brief Summary

2019 Results article in https://pubmed.ncbi.nlm.nih.gov/30822414/ (added 03/08/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-16
• Study Completion: 2019-10-02
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1. Aged 16 years or older
2. Able to fully understand study requirements and attend all follow-up visits (in the opinion of the investigator)
3. Weigh between 40 and 150 kg with a body mass index 20-35 kg/m² (as described in the Quetelet’s index – weight (kg)/height² (m))

Exclusion Criteria

1. Known allergy to any components of the topical formulation
2. History or evidence of keloid scarring or fibrotic disorders (self reported or determined by physical examination)
3. Pregnant or planning to conceive within the next 3 months
4. Chronic or active skin disorder considered to adversely affect the scar healing by the investigator
5. Likely healing impairment due to a significant medical condition such as renal, hepatic, haematological, neurological or immune disease, including rheumatoid arthritis, chronic renal impairment, diabetes mellitus, significant hepatic impairment, inadequately or uncontrolled congestive heart failure, malignancy (diagnosed or treated within the past 5 years) or immunosuppressive, radiation or chemotherapy within the last three months.
6. Receiving anticoagulant therapy, systemic steroids, hormone replacement therapy or any investigational drugs, or have taken any in the previous month prior to Day 0
7. Evidence of drug abuse
8. Had or are known to have serum hepatitis or are carriers of hepatitis B surface antigen, hepatitis B core antibodies or hepatitis C antibodies (previous vaccination against hepatitis B or C is not excluded)
9. Previously had a positive result to the HIV antibody test, or admit to belong in a high risk group
10. Allergic to other amide local anaesthetics

Subjects who have been involved in other studies in the past two months prior to Day 0 must discuss the exact details of the previous studies prior to a decision being made of eligibility for inclusion in this trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified