A Phase 4 interventional study of Triamcinolone and Lidocaine in Scar Keloid and Hypertrophic Scar, sponsored by Kaohsiung Medical University. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-06-17.
Sponsored by Kaohsiung Medical University · Phase 4, Interventional, and Treatment
Botulinum toxins has been approved by the FDA to treat chronic migraine. Botox had been shown to inhibiting the release of inflammatory mediators and peripheral neurotransmitters from sensory nerve to treat neuropathic pain. In the clinical practice, botox indeed effect in scar pain. However, investigators need well controlled study to prove this finding and assess the improvement of scar appearance.
After surgery or trauma, scar tissues would form during the healing process. However, hypertrophic scars and keloids might happen to some patients, both of which are often pruritic and erythematous. Besides, the markedly elevated tumor-like appearance usually brings much concern to patients. Moreover, significant pain or discomfort could happen to keloids. Various treatment strategies were mentioned but without a solid solution to all of the scars. Investigators hope to evaluate the differences of scar volume, appearance and symptoms (itching and pain) in participants receiving simultaneous intralesional injection of Botulinum toxin type A and/or steroids. Besides, side effects would also be recorded. Investigators hope to establish a more effective intralesional injection therapy for participatns suffering from hypertrophic scars and keloids.
123 studies on the registry are indexed under Keloid; 23 are open to participants now.
This study's planned enrollment of 20 is below the median of 30 across 97 interventional studies indexed under Keloid.
Browse Keloid studies →Kaohsiung Medical University is the lead sponsor of 55 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
0.9% Normal saline 0.1 ml +Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1cm2 scar volume
Drug: Triamcinolone · Drug: Lidocaine
4U Botox® diluted to 0.1 ml + Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1 cm2 scar volume
Drug: Triamcinolone · Drug: Lidocaine · Drug: Botulinum toxin A
Triamcinolone 4mg diluted to 0.1 ml
Also known as: steroid
0.1ml 2% Xylocaine
Also known as: Xylocaine
4U Botox® diluted to 0.1 ml
Also known as: botox
Scar pain relief
assessed by score 0,1,2 (0: no pain, 1: sometimes feel pain, 2: need medication)
Time frame: Change from baseline scar pain during 16 weeks after drug injection
scar appearance
assessed by vancouver scar scale(vascularity, pigmentation, pliability, height)
Time frame: Change from baseline scar appearance during 16 weeks after drug injection
itch
assessed by score 0,1,2 (0: no itch, 1: sometimes feel itch, 2: need medication)
Time frame: Change from baseline itch sensation during 16 weeks after drug injection
This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Kaohsiung Medical University