How Does an Over the Counter Topical called MEBO Scar™ Cosmetically Improve Skin Scars?
| ISRCTN | ISRCTN16551998 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16551998 |
| Secondary identifying numbers | Ethical committee UREC ref 16098 |
- Submission date
- 04/06/2018
- Registration date
- 07/06/2018
- Last edited
- 14/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
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.
This study aims to investigate how the topical application (surface application) of an over the counter cream called MEBO Scar™ cosmetically improves skin scarring and to determine what changes occur in the new scar tissue and cells.
Who can participate?
Healthy volunteers aged over 18 years
What does the study involve?
Participants undergo an ‘initial study appointment’ (Day 0) where they receive a punch biopsy to create a scar on both upper inner arms. Two weeks later they are asked to apply a topical cream to each of the scars during the study period. During this period they are seen on a fortnightly basis where photographic images are taken of the scars at each visit along with other measurements looking at properties of the scar. Each participant also keeps a diary of how the scar changes over time.
Participants may be in the study for 4 weeks or up to 16 weeks, depending on which group they are allocated to (at random). At the final appointment the scars are biopsied so that they can be evaluated in the lab for further analysis of the effects of both topicals. At that point the participant can leave the trial.
We aim to offer flexible appointments (i.e. early or late appointments). Each visit lasts approximately 30-60 minutes. At the end of the trial all the data is analysed and will answer the question of whether MEBO ScarTM can improve cosmetic scarring.
What are the possible benefits and risks of participating?
There are 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?
Manchester University NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
January 2016 to May 2017
Who is funding the study?
Julphar Gulf, Pharmaceutical Industries (UAE)
Who is the main contact?
Dr Rubinder Basson (scientific)
rubinder.basson@postgrad.manchester.ac.uk
Contact information
Scientific
Plastic and Reconstructive Surgery Research
Division of Musculoskeletal and Dermatological Sciences
Manchester Academic Health Science Centre
University of Manchester
Stopford Building
Oxford Road
Manchester
M13 9PL
United Kingdom
 ORCID ID |
0000-0002-5470-1473 |
|---|
Study information
| Study design | Interventional randomised blinded single centre design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN16551998_PIS-v1_06Jun18.doc |
| Scientific title | Role of MEBO ScarTM cream in enhancing the appearance of cosmetic scars |
| Study hypothesis | To evaluate the scar cosmetic appearance - that scars treated with Meboscar TM will have a more improved appearance compared to a positive control (scars treated with Kelo-coteTM) |
| Ethics approval(s) | University of Manchester Ethics Committee 4 UREC, 21/07/2016, ref: 16098 |
| Condition | Cosmetic skin scarring |
| Intervention | Participants are screened and allocated into four groups. Each group represents a time point (4, 8, 12, 16 weeks). Participants receive 5 mm punch biopsies to both upper inner arms to create the scar. They are independently randomised as to which arm should receive either treatment or positive control topicals. Treatment: MeboscarTM Control: Kelo-coteTM Participants apply both topicals according to instructions, (one to each scar, with arms independently randomised by a medical statistician at the University of Manchester). Depending on which group they are in, receive their final biopsy (of the scars) at this time point where they exit the trial. Topicals are applied from two weeks after the scar is created (on day 0), and up until the point that participant exits the trial (at 4, 8, 12, or 16 weeks). Topicals are applied twice daily, massaged into the scar for a period of 2 minutes. Non-invasive measurements are taken on a fortnightly basis for each participants' duration of the trial. Final scar biopsies are used for histological, gene and protein analysis. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | - |
| Primary outcome measure | Skin/scar hydration and trans-epidermal water loss is measured using the Dermalab combo (Cortex technologies, Denmark), validated by IHC of hyaluronic acid and qPCR of HYAL 1 and HAS 1. Colour is measured using the Dermalab combo colour probe (Cortex technologies, Denmark) Pigmentation is measured using SIAscopy (Medex Health, Canada) - IHC for Melan A and Masson fontana to look for pigmentation Erythema is measured using Dermalab combo colour probe (Cortex technologies, Denmark), and SIAscropy (Medx Health, Canada); mast cell tryptase staining Blood flow is measured using FLPI-2 (Moor Instruments, UK), and OCT (Michelson Diagnostics, UK) Elasticity is measured using Dermalab combo elasticity probe (Cortex Technologies, Denmark), validated by IHC stains for elastin, and fibronectin, with qPCR of elastin and fibronectin. Collagen is measured using SIAscopy (Medx Health, Canada) and validated by IHC staining for Collagen I and III, and Herovici staining, and qPCR for COL I and III. H&E staining is also done on all samples to look at skin/scar thickness and structure. Transdermal delivery of the topical is also assessed using HPLC and Raman spectroscopy. All of the above are measured for normal skin (day 0) and at weeks 4, 8, 12 and 16. |
| Secondary outcome measures | Pain, itching and redness are evaluated by the patient using a numerical value out of 10 in a daily diary. |
| Overall study start date | 04/01/2016 |
| Overall study end date | 31/05/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Participant inclusion criteria | 1. Male or female over 18 years old 2. Between 40-150kg (BMI 20-35) 3. Able to understand study requirements and provide written consent |
| Participant exclusion criteria | 1. Participants who do not give consent to take part in the study 2. Any subject who in the opinion of the investigator is unable to fully understand the requirements of the trial (for example due to a language barrier), consent or is unable to return for follow-up visits and complete the trial 3. Known allergy to any components of the topical formulation 4. Individuals less than 18 years of age will be excluded from the study 5. Individuals who have a history or evidence of keloid scarring or fibrotic disorders (self reported or determined by physical examination) 6. Participants who are pregnant or are planning to conceive in the next 3 months 7. Participants with a chronic or active skin disorder considered to adversely affect the scar healing by the investigator 8. Participants with any likely healing impairment due to a significant medical condition such as renal, hepatic, haematological, neurological or immune disease, including: 9. Rheumatoid arthritis 10. Chronic renal impairment 11. Diabetes Mellitus 12. Significant hepatic impairment 13. Inadequately or uncontrolled congestive heart failure 14. Malignancy – diagnosed or treated within the past 5 years 15. Immunosuppressive, radiation or chemotherapy within the last three month 16. Participants who are receiving anticoagulant therapy, systemic steroids, hormone replacement therapy or any investigational drugs, or have taken any in the previous month prior to Day 0 17. Participants who have evidence of drug abuse 18. Participants who 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) 19. Participants who have previously had a positive result to the HIV antibody test, or admit to belong to a high risk group 20. Participants 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 21. Exclude participants who are allergic to other amide local anaesthetics 22. Previous MRSA colonisation or infection |
| Recruitment start date | 01/08/2016 |
| Recruitment end date | 01/04/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
M23 9LT
United Kingdom
Sponsor information
University/education
Stopford Building
Oxford Road
Greater Manchester
M13 9PL
England
United Kingdom
"ROR" |
https://ror.org/027m9bs27 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Rubinder Basson, rubinder.basson@postgrad.manchester.ac.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v1 | 06/06/2018 | 02/04/2019 | No | Yes |
| Results article | 01/02/2019 | 14/07/2023 | Yes | No |
Additional files
- ISRCTN16551998_PIS-v1_06Jun18.doc
- Uploaded 02/04/2019
Editorial Notes
14/07/2023: Publication reference added.
02/04/2019: The participant information sheet has been uploaded.
