The role of an over the counter topical containing green tea extract in scarring

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2018
INTERVENTION: 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 scar. 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). Depending on which group they are in, receive their final biopsy (of the scars) at this time point where they then complete the trial. Topicals are applied from two weeks after the scar is created for 5 of the groups and immediately for 2 of the groups (on day 0), and up until the point that participant exits the trial (at 1,2,3,4,5,6,8 weeks). 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. CONDITION: Cosmetic skin scarring ; Skin and Connective Tissue Diseases ; Cosmetic skin scarring PRIMARY OUTCOME: 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 OUTCOME: Symptom scoring including pain, itching and redness are evaluated by the patient using a numerical value out of 10 in a daily diary. 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))
Epistemonikos ID: a1bbe0e67101580eec35cb956014d3cf9ee56694
First added on: Aug 24, 2024