Keloid Lesion. Diseases of skin and soft tissue
Conditions
Interventions
Intervention 1: Each patient receives botulinum toxin type A with concentration 200 units per ml with the dose of 10 or 20 units per cubic centimeter lesion in a part of the lesion. In another part of
Treatment - Drugs
Each patient receives botulinum toxin type A with concentration 200 units per ml with the dose of 10 or 20 units per cubic centimeter lesion in a part of the lesion. In another part of the lesion, nor
In group two of intervention, each lesion receives botulinum toxin type A with concentration 200 units per ml with the dose of 20 units per cubic centimeter lesion in a part of the lesion. Injections
In the first control group, another part of the lesion, receives normal saline with the same volume of botulinum toxin type A was injected in group one. Injections have been done monthly to three time
In the second control group, another part of the lesion, receives normal saline with the same volume of botulinum toxin type A was injected in group two. Injections have been done monthly to three tim
Sponsors
School of Medicine, Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
12 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: patients with keloid lesion greater 2cm; patient age between 12-65 years of old; patients consent to participate in the study; Exclusion criteria: patients with keloid lesion smaller than 1.9cm; lack of patient satisfaction in doing a research intervention; sensitivity to BTX-A; pregnant and breastfeeding women; patients with neuromuscular diseases.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pigmentation. Timepoint: 0-9monthes after last intervention. Method of measurement: By observers.;Vascularity. Timepoint: At beginig and 9th monthes after last injection. Method of measurement: By observers.;Height. Timepoint: At beginig and 9th monthes after last injection. Method of measurement: By observers.;Pliability. Timepoint: At beginig and 9th monthes after last injection. Method of measurement: By observers. | — |
Secondary
| Measure | Time frame |
|---|---|
| Peri-lesional atrophy. Timepoint: At the begining of the study and 9 monthes after last injection. Method of measurement: assessment by ruler. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Afshin Fathi
School of Medicine, Tehran University of Medical Sciences
Outcome results
None listed