Plain English Summary
Background and study aims
A scar is a natural part of healing. Most people produce fine, thin scars but this can depend on a number of factors. It is thought that a long time for wound healing and skin closure can cause thicker, more raised scars. These unsatisfactory scars are often itchy, painful and cause distress to the sufferers.
The antioxidant properties and health benefits of green tea, Camellia sinensis, a popular beverage, have been known for centuries and used in traditional Chinese medicine. A component of green tea, has been shown to influence a range of areas including cancer, inflammation, photo protection, anti-aging and wound healing.
In the first stage of this trial we have shown that a topical cream known as EGCG (green tea) had beneficial effects in improving scars.
Therefore, we postulated that priming of the zone of injury prior to performing the experimental tissue damage could further maximise these effects by targeting the source of inflammation earlier. The aim is to further understand the role of EGCG in priming the wound site.
Who can participate?
Healthy volunteers aged at least 18 years
What does the study involve?
Participants will be given two punch biopsies to create controlled scars in a concealed place on the inner upper arm. Participants are split into four groups, each group will receive skin treatment application at different times. In each group participants will be randomly given either the active treatment (green tea extract) or a placebo to apply to the scars twice a day. Biopsies are performed again at week 4 and week 8. Measurements of skin condition are taken weekly for the duration of the trial.
What are the possible benefits and risks of participating?
There were no direct benefits to participants in this study. Participants are carefully screened so that risks to them taking part (i.e. allergies to any of the topicals or local anaesthetic/dressings) are minimised. They are however left with a scar, which may take time to fade.
Where is the study run from?
Wythenshawe Hospital (UK)
When is the study starting and how long is it expected to run for?
December 2015 until September 2019
Who is funding the study?
Funded by a gift donation
Who is the main contact?
Sara Ud-din, sara.ud-din@manchester.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Miss Sara Ud-Din
ORCID ID
http://orcid.org/0000-0002-9791-1403
Contact details
Plastic and Reconstructive Surgery Research
Division of Musculoskeletal and Dermatological Sceiences
Manchester Academic Health Science Centre
University of Manchester
Stopford Building
Oxford Road
Manchester
M13 9PT
United Kingdom
+44 (0)161 306 0663
sara.ud-din@manchester.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
The role of an over-the-counter topical containing Camellia sinensis in the cosmetic management of skin scars in priming the skin prior to injury
Acronym
Study hypothesis
To evaluate the role of topical application of Camellia sinensis in scar cosmetic appearance against a placebo and the effects of priming the zone of injury
Ethics approval
Approved 02/10/2014, University of Manchester Ethics Committee 4 (University Research Ethics Committee, Research Governance, Ethics and Integrity, 2nd Floor Christie Building, The University of Manchester, Oxford Road, Manchester, M13 9PL, UK; +44 (0)161 275 2206/2674; research.ethics@manchester.ac.uk), ref: 14333
Study design
Interventional randomized controlled blinded single-centre design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Skin scarring
Intervention
40 participants were screened and split equally into 4 groups. Each group represents a mode of topical application.
Group 1: Pre-emptive Priming 7 days – Application of topicals 7 days prior to initial biopsies on day 0
Group 2: Pre-emptive Priming 3 days – Application of topicals 3 days prior to initial biopsies on day 0
Group 3: Immediate delivery – Immediate application of topicals on day 0 (initial biopsies)
Group 4: Delayed delivery – Delayed application of topicals 2 weeks post-initial biopsies
On day 0, participants received two 5 mm punch biopsies to both upper inner arms to create the scars. They are independently randomised as to which arm should receive either treatment or placebo topicals.
Treatment: Camellia Sinensis (Green Tea extract)
Placebo: Same base as treatment topical but no active ingredient
Participants apply both topicals according to instructions, (one to each scar, with arms independently randomised by a medical statistician at the University of Manchester).
6mm re-biopsies were performed at weeks 4 and week 8.
Topicals are applied twice daily, massaged into the scar for a period of 2 minutes.
Non-invasive measurements are taken on a weekly basis for each participants' duration of the trial.
Final scar biopsies are used for histological, gene and protein analysis.
This is the second stage of ISRCTN18643079.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Elasticity is measured using Dermalab combo elastin probe (Cortex technologies, Denmark) validated by IHC stains for elastin
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
3. High frequency ultrasound (Cortex Technologies, Denmark) measures skin thickness
4. RNA sequencing and QRT-PCR performed to validate IHC analyses.
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).
All IHC, PCR and mRNA sequencing were used on Day 0, Week 4 and Week 8.
Secondary outcome measures
Symptom scoring including pain, itching and redness are evaluated by the patient using a numerical value out of 10 in a daily diary
Overall trial start date
23/08/2013
Overall trial end date
12/09/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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))
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
40
Total final enrolment
40
Participant 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 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
Recruitment start date
22/12/2015
Recruitment end date
12/09/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wythenshawe Hospital
Clinical Research Facility
Manchester University NHS Foundation Trust
Southmoor Road
Manchester
M23 9LT
United Kingdom
Sponsor information
Organisation
University of Manchester
Sponsor details
Stopford Building
Oxford Road
Manchester
M13 9PT
United Kingdom
+44 (0)161 306 6000
research.ethics@manchester.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
A gift donation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in high-impact peer reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Sara Ud-Din, sara.ud-din@manchester.ac.uk
Intention to publish date
30/07/2020
Participant level data
Available on request
Basic results (scientific)
Publication list