Cosmetic skin scarring Skin and Connective Tissue Diseases Cosmetic skin scarring
Conditions
Interventions
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 sca
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Pain, itching and redness are evaluated by the patient using a numerical value out of 10 in a daily diary. | — |
Countries
England, United Kingdom
Outcome results
None listed