Cosmetic skin scarring Skin and Connective Tissue Diseases Cosmetic skin scarring
Conditions
Interventions
Participants are screened and allocated into seven groups. Each group represents a time point (1,2,3,4,5,6,8 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. 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scar 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 SIAscopy (Medx Health, Canada); mast cell tryptase and chymase staining Blood flow is measured using FLPI-2 (Moor Instruments, UK), and OCT (Michelson Diagnostics, UK), ultrasound (Cortex Technologies, Denmark) measures skin thickness. Elasticity is measured using Dermalab combo elasticity probe (Cortex Technologies, Denmark), validated by IHC stains for elastin, and fibronectin. Collagen is measured using SIAscopy (Medx Health, Canada) and validated by IHC staining for Collagen I and III, and Herovici staining. H&E staining is performed on all samples to look at scar morphology. RNA sequencing and QRT-PCR performed to validate IHC analyses. All of the above measurements were taken on a weekly basis through the duration of the trial. All of the above are measured for normal skin (day 0) and at weeks 1,2,3,4,5,6,8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom scoring including pain, itching and redness are evaluated by the patient using a numerical value out of 10 in a daily diary. | — |
Countries
United Kingdom
Outcome results
None listed