The role of an over-the-counter green tea extract in scarring: Priming the skin prior to injury
- Conditions
- Skin scarringSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN70155584
- Lead Sponsor
- niversity of Manchester
- Brief Summary
2021 results in https://pubmed.ncbi.nlm.nih.gov/33917842/ (added 05/05/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
1. Aged 18 years and older
2. Able to fully understand the study requirements and attend all follow-up visits.
3. Provide written informed consent to participate in the study.
4. Appropriate size and weight - between 40 and 150kg, with a body mass index 20-35 kg/m² (as described in the Quetelet’s index – weight (kg)/height² (m))
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 are planning to conceive in the next 3 months
4. Chronic or active skin disorder considered to adversely affect the scar healing by the investigator
5. Any likely healing impairment due to a significant medical condition such as renal, hepatic, haematological, neurological or immune disease, including:
5.1. Rheumatoid arthritis
5.2. Chronic renal impairment
5.3. Diabetes Mellitus
5.4. Significant hepatic impairment
5.5. Inadequately or uncontrolled congestive heart failure
6. Malignancy – diagnosed or treated within the past 5 years
7. Immunosuppressive, radiation or chemotherapy within the last three month
8. Receiving anticoagulant therapy, systemic steroids, hormone replacement therapy or any investigational drugs, or have taken any in the previous month prior to Day 0
9. Evidence of drug abuse
10. Have 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 and C is not excluded.
11. Previously had a positive result to the HIV antibody test, or admit to belonging to a high-risk group.
12. 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
13. Allergic to other amide local anaesthetics
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Elasticity is measured using Dermalab combo elastin probe (Cortex technologies, Denmark) validated by IHC stains for elastin<br> 2. Blood flow is measured using FLPI-2 (Moor Instruments, UK), and OCT (Michelson Diagnostics, UK) validated by IHC stains for multiple immune cells including mast cells, and angiogenic markers including CD31 and VEGF-A<br> 3. High frequency ultrasound (Cortex Technologies, Denmark) measures skin thickness<br> 4. RNA sequencing and QRT-PCR performed to validate IHC analyses.<br><br> All clinical devices (Elasticity probe, FLPI, OCT and Ultrasound) are measured at weekly time points (Day 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8).<br> All IHC, PCR and mRNA sequencing were used on Day 0, Week 4 and Week 8.<br>
- Secondary Outcome Measures
Name Time Method Symptom scoring including pain, itching and redness are evaluated by the patient using a numerical value out of 10 in a daily diary