Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT04736251
Eligibility Criteria:
Inclusion Criteria:
* Adult patients aged ≥ 16years
* Patient with hypertrophic scarring as a result of deep dermal or full thickness burns/trauma.
* Trauma or Burn sustained more than 12 months prior to recruitment.
* Treatment area to be ≥25cm2 confluent scarring with a comparable control scar on limb or trunk
General Exclusion Criteria:
* Patients under 16 years of age
* Previous laser therapy treatment to the study site
* The use of recent (within 6 months) or concurrent invasive scar treatments, including intra-lesional pharmaceuticals, micro needling or other laser modalities (e.g. Pulse-dye.)
* Known allergy or contraindication to EMLA™ 5% Cream (Lidocaine 2.5% and Prilocaine 2.5%), Dermol 500TM (Benzalkonium Chloride 0.1%; Chlorhexidine Dihydrochloride 0.1%; Liquid Paraffin 2.5%; Isopropyl Myristate 2.5%) or 50:50 ointment (White Soft Paraffin Liquid Paraffin %w/w 50 50.)
* Patients with Fitzpatrick skin type of 5-6 due to nature of the skin
Laser Treatment Exclusion Criteria
* The presence of acute infection at the proposed treatment site
* Pregnancy or lactation
* Patients with poorly controlled Diabetes mellitus HbA1C \>9% or 75mmol/mol within last 3 months)
* Patients experiencing acute exacerbation of Chronic skin diseases e.g. psoriasis or eczema
* Immunosuppression (HIV, drugs with immunosuppressive effect)
* Use of Roaccutane at any time within the last 6 months
* Autoimmune disorders in active stage (for example: 1. Localised; Type 1 Diabetes Mellitus, Addison's, Grave's and Crohn's Disease, 2. Systemic; Rheumatoid Arthritis, Multiple Sclerosis, Lups and Scleroderma).
* Known history of keloid scarring
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT04736251
Study Brief:
Protocol Section:
NCT04736251