Department of Dermatology, Seoul National University College of Medicine
Seoul, 110-744, South Korea
Completed
NCT Number: NCT01895374
Clinical Efficacy of Bovine Freeze-dried Amniotic Membrane on Wound Healing in Laser Treatment
Bovine amniotic membrane may show better efficacy than hydrocolloid dressing.
Completed
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Conditions
Age range
19 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
Bovine amniotic membrane as a biological dressing can be applicable to wound after laser treatments. Comparing with hydrocolloid dressing material, which is the most widely used after laser treatment now, amniotic membrane will show better efficacy. Thus, with amniotic membrane, epithelization time will shorten and redness which is usually left after laser will disappear quickly.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Skin lesions treatable by ablative lasers
- More than two skin lesions of similar size at the same area
- Available during the study period (2 weeks)
Exclusion criteria
- Taking steroid or nonsteroidal antiinflammatory drug, isotretinoin
- underlying diabetes mellitus, keloid or any malignancy
Treatment and study plan
laser treatments
ProcedureOther names: Laser ablation of the skin lesions
Amniotic Membrane Application
OtherOther names: dressing with amniotic membrane
hydrocolloid application
DeviceOther names: dressing with hydrocolloid as a comparator
Primary outcomes
-
Epithelization time
Time frame: 2 weeks
time to complete epithelization after wounding
Secondary outcomes
-
Epithelization Scale
Time frame: 2 weeks
Assessment of redness, oozing, swelling
-
Photometric measurements
Time frame: 2 weeks
spectrophotometer and colorimeter
-
Vancouver scar scale
Time frame: 2 weeks
Vancouver scar scale
-
Assessment by subjects
Time frame: 2 weeks
pain, itching, inconvenience
-
measurements of adverse effects
Time frame: 2 weeks
assessments of adverse effects by investigator
-
histopathologic analysis
Time frame: 2 weeks
changes of the tissue with time
Sponsors and collaborators
Lead sponsor
Seoul National University Hospital
Other
Registry information
Official study title
A Comparison of the Effects of Bovine Freeze-dried Amniotic Membrane and Hydrocolloid on Epithelialization After Laser Treatments
Important dates
- Study start
- 2012
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Jul 10, 2013
- Registry last updated
- Jul 10, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.