Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03982862
Other study ID # KMUHIRB-F(II)-20180062
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date July 30, 2018
Est. completion date June 30, 2019

Study information

Verified date June 2019
Source Kaohsiung Medical University
Contact Shu hung Huang, MD, PHD
Phone 886-3121101
Email huangsh63@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date June 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

1. Patients have visible hypertrophic scars or keloids over three months after trauma or surgery.

2. Patients have symptoms of pain, itching or erythema.

Exclusion Criteria:

1. Patients had either Botulinum toxin type A or Triamcinolone intralesional before in the same scar

2. The scar size is larger than 10 cm2

3. Immunocompromised status

4. Systemic infection status

5. Allergic to Botulinum toxin type A or steroids

Study Design


Intervention

Drug:
Triamcinolone
Triamcinolone 4mg diluted to 0.1 ml
Lidocaine
0.1ml 2% Xylocaine
Botulinum toxin A
4U Botox® diluted to 0.1 ml

Locations

Country Name City State
Taiwan Kaohsiung Medical University Hospital Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Kaohsiung Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Scar pain relief assessed by score 0,1,2 (0: no pain, 1: sometimes feel pain, 2: need medication) Change from baseline scar pain during 16 weeks after drug injection
Primary scar appearance assessed by vancouver scar scale(vascularity, pigmentation, pliability, height) Change from baseline scar appearance during 16 weeks after drug injection
Primary itch assessed by score 0,1,2 (0: no itch, 1: sometimes feel itch, 2: need medication) Change from baseline itch sensation during 16 weeks after drug injection
See also
  Status Clinical Trial Phase
Completed NCT03376620 - Role of Topical Putrescine (Fibrostat) for Prevention of Hypertrophic Scars in Mammoplasty Patients Phase 3
Terminated NCT03935594 - Use of Autologous Platelet-Rich Plasma to Treat Hypertrophic Burn Scars Phase 2
Recruiting NCT03561376 - Zinc Oxide Versus Petrolatum Following Skin Surgery Early Phase 1
Recruiting NCT06033430 - Effectiveness of Dry Needling in Linear Scar Tissue N/A
Recruiting NCT03631368 - Treatment of Hypertrophic Scars With Intradermal Botox Phase 2
Completed NCT03630198 - Pain Outcomes Following Intralesional Corticosteroid Injections Phase 4
Recruiting NCT02168634 - The Use of Botulinum Toxin in the Treatment of Itching From Hypertrophic Scar -- A Randomised Controlled Trial N/A
Completed NCT02030275 - A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery in Healthy Adults Phase 2
Recruiting NCT04506255 - Silicone Taping for the Improvement of Abdominal Donor Site Scars N/A
Not yet recruiting NCT04593706 - Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars) N/A
Completed NCT04643223 - Effect of Elastic Bandage With Tension on the Inflammatory Response of Hypertrophic Scars N/A
Completed NCT03986346 - The Vascularity Changes of Scars With Laser Therapy N/A
Completed NCT04619589 - Characterization of Dyschromic Hypertrophic Scar
Completed NCT05412745 - Class I Medical Device on Post-surgical Scars N/A
Completed NCT06347081 - Effect of Nd-YAG Laser on Hypertrophic Scar N/A
Terminated NCT03403621 - Hypertrophic Scar Prevention by Novel Topical Gel Application Phase 1/Phase 2
Completed NCT00754247 - A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars Phase 4
Recruiting NCT03692273 - Randomized Control Trial of CO2 Laser to Treat Hypertrophic Burn Scar N/A
Completed NCT03795116 - Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention Phase 2
Not yet recruiting NCT03850119 - Nanofat on Wound Healing and Scar Formation N/A