A common asthma drug, applied directly to healing skin wounds, can reduce scarring by shifting the body’s repair process toward normal regeneration rather than excessive scar tissue. Scarring affects millions of people after surgery, especially when incisions are made in areas of high tension. Darkening of the scar (hyperpigmentation) can make even minor injuries traumatic, and there are currently no proven treatments to prevent wound scarring. The problem is both personal—affecting appearance and joint movement—and financial, burdening healthcare systems with the cost of scar revision surgeries. If this trial succeeds, a simple topical gel could become a routine part of wound care after surgery. Patients would heal with less visible scarring, avoid hyperpigmentation, and need fewer follow-up procedures. For the NHS, that means shorter hospital stays and lower costs. The same approach might eventually be used to prevent keloids—raised, progressively enlarging scars—and even fibrosis in other tissues. This is a translational clinical trial, not fundamental science. It takes a well-established drug with a known safety profile and repurposes it for a new use, moving directly toward a practical treatment.
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One hundred and ten million primary surgical incisions occur globally every year, with those made in areas of high tension particularly prone to scarring. Scarring is the result of the natural process of wound repair, generated by excessive cell behaviour in the healing wound. Depending on the body location, wound scars can be emotionally (face) and physically (joint) debilitating. This is especially true for some patients who suffer significant darkening (hyperpigmentation) of the skin at the site of damage, making any injury particularly traumatic. In addition, the care of wound scars places a heavy financial burden on healthcare systems worldwide. An effective scar prevention treatment would benefit the millions of patients with skin injury, enhancing the patient's health and quality of life. There are currently no proven treatments available to prevent wound scarring. Salbutamol is a safe and well-tolerated pharmaceutical, which has been a mainstay of asthma therapy in the UK since 1968. Research in the Pullar lab and other labs has shown that salbutamol can modulate wound repair processes. Uniquely, when salbutamol is applied to the wound site, it alters the way the wound heals, curbing excessive cell behaviour and moving the healing process away from scarring and towards normal skin regeneration. In a pig wound model, salbutamol reduced scar area and hyperpigmentation by almost 50%, 56 days post-wounding, significantly improving scar appearance. Here, stable salbutamol and placebo gels will be manufactured for topical use in skin wounds in accordance with good manufacturing practices. Non-clinical studies will be performed in a pig wound model in accordance with good laboratory practices to ensure safety (pharmacokinetic (PK) studies and skin toxicology), to satisfy regulatory requirements and determine the optimum 1x dose for skin scar prevention in the first-in-human clinical trial (CT). To move towards therapeutic implementation, the phase I CT is designed as a within-volunteer, double-blind, randomised, placebo-controlled dose escalation trial. A robust recruitment plan will recruit 45 healthy volunteers who will be recruited into three groups of 0.5x, 1x (selected from the pre-CT) and 2x salbutamol formulation, starting with the lowest dose. The study, performed in accordance with good clinical practice, will be for 12 months. 2cm linear incisions will be made at the same anatomical location under each arm of volunteers and placebo and salbutamol dose will be randomised between left and right arms. Incisions will be treated daily for 60 days. The primarily trial objective will be to assess safety and tolerability of topical salbutamol when applied to linear incisions. Blood samples will be collected at day 0/1 after surgery to perform PK analysis to determine if peak salbutamol plasma levels are acceptable. Skin tolerance will be assessed at each site daily. Adverse events will be recorded. Interim analysis of safety will be provided after the 0.5x dose to progress to the higher dose. The secondary objective is to determine the optimal topical salbutamol dose for scar improvement. Wound healing and scar assessments will compare the active dose and placebo in each volunteer's paired, contralateral scars at 6, 9 and 12 months post-wounding, when scars are considered fully mature. The data will determine whether this study will pave the way for further CTs within patients with surgical procedures prone to scarring. In addition to the benefit to patients, this treatment would also benefit the surgeons and the NHS. Patients would heal better, leave hospital sooner and require less scar revision surgery, which would provide significant cost savings. Demonstrated efficacy in skin scar prevention could pave the way to the use of salbutamol to prevent excessive skin scarring (keloids - raised, progressively enlarging scars at the wound site) and fibrosis in other tissues.
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