Back to resultsTopical Agents Containing Magnesium Sulfate & Wound Healing in the Rat Model
Primary Purpose
Wound Heal
Status
Unknown status
Phase
Early Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
placebo comparator
sham comparator
Experimental drug 1
Experimental drug 2
Centella asiatica
Sponsored by
About this trial
This is an interventional treatment trial for Wound Heal focused on measuring magnesium sulphate, wound healing rat model, hydroxyproline
Eligibility Criteria
Inclusion Criteria:
- healthy rats between ages of 8- 12 weeks
Exclusion Criteria:
- weight loss of more than 15% of body weight
Sites / Locations
- Başakşehir Çam Ve Sakura Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Sham Comparator
Experimental
Experimental
Active Comparator
Arm Label
Group placebo
Group sham
Group %1 mgso4
Group %10 MgSO4
Group positive control
Arm Description
Isotonic solution will be administered daily to 6 female rats.
Base cream to be applied twice a day to 6 female rats.
Cream containing 1% MgSO4 will be applied twice a day to 6 female rats.
Cream containing 10% MgSO4 will be applied twice a day to 6 female rats.
Cream containing centella asiatica will be applied twice a day to 6 female rats.
Outcomes
Primary Outcome Measures
7th day evaluation
Histopathological evaluation of wound healing comparing with the rate of vascular endothelial growth factor (VEGF), transforming growth factor (TGF-beta) and hydroxyproline at immunohistochemical staining with biopsy on the 7th day.
Secondary Outcome Measures
15th day evaluation
Histopathological evaluation of wound healing comparing with the rate of VEGF, TGF-beta and hydroxyproline at immunohistochemical staining with biopsy on the 15th day.
Full Information
NCT ID
NCT04886882
First Posted
April 13, 2021
Last Updated
May 10, 2021
Sponsor
Basaksehir Cam & Sakura Şehir Hospital
Collaborators
Istanbul Kent University
1. Study Identification
Unique Protocol Identification Number
NCT04886882
Brief Title
Topical Agents Containing Magnesium Sulfate & Wound Healing in the Rat Model
Official Title
The Effect of Topical Agents in Cream Formations Containing Magnesium Sulfate on Wound Healing in the Rat Model
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Basaksehir Cam & Sakura Şehir Hospital
Collaborators
Istanbul Kent University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
An experimental study examining wound healing in 5 different groups on 30 rats.
Detailed Description
Magnesium topically increases collagen synthesis and angiogenesis, providing faster and higher quality wound healing. In addition, with its analgesic effect, it will also eliminate the pain sensation caused by the wound and increase the quality of life of the patient whose skin integrity is impaired.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal
Keywords
magnesium sulphate, wound healing rat model, hydroxyproline
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group placebo
Arm Type
Placebo Comparator
Arm Description
Isotonic solution will be administered daily to 6 female rats.
Arm Title
Group sham
Arm Type
Sham Comparator
Arm Description
Base cream to be applied twice a day to 6 female rats.
Arm Title
Group %1 mgso4
Arm Type
Experimental
Arm Description
Cream containing 1% MgSO4 will be applied twice a day to 6 female rats.
Arm Title
Group %10 MgSO4
Arm Type
Experimental
Arm Description
Cream containing 10% MgSO4 will be applied twice a day to 6 female rats.
Arm Title
Group positive control
Arm Type
Active Comparator
Arm Description
Cream containing centella asiatica will be applied twice a day to 6 female rats.
Intervention Type
Other
Intervention Name(s)
placebo comparator
Intervention Description
solution containing 0.9 % sodium chlorine
Intervention Type
Other
Intervention Name(s)
sham comparator
Intervention Description
vaseline, beeswax,polyglyceryl-3 diisostearate, sorbitan caprylate, propandiol,benzoic acid, glycerin, water
Intervention Type
Other
Intervention Name(s)
Experimental drug 1
Intervention Description
A cream containing 10 % MgSO4.vaseline, beeswaxpolyglyceryl-3 diisostearate, sorbitan caprylate, propandiol,benzoic acid, glycerin, water
Intervention Type
Other
Intervention Name(s)
Experimental drug 2
Intervention Description
A cream containing 10 % MgSO4.vaseline, beeswax,polyglyceryl-3 diisostearate, sorbitan caprylate, propandiol,benzoic acid, glycerin, water
Intervention Type
Drug
Intervention Name(s)
Centella asiatica
Intervention Description
A cream containing Centella asiatica
Primary Outcome Measure Information:
Title
7th day evaluation
Description
Histopathological evaluation of wound healing comparing with the rate of vascular endothelial growth factor (VEGF), transforming growth factor (TGF-beta) and hydroxyproline at immunohistochemical staining with biopsy on the 7th day.
Time Frame
7th day
Secondary Outcome Measure Information:
Title
15th day evaluation
Description
Histopathological evaluation of wound healing comparing with the rate of VEGF, TGF-beta and hydroxyproline at immunohistochemical staining with biopsy on the 15th day.
Time Frame
15th day
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
8 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy rats between ages of 8- 12 weeks
Exclusion Criteria:
weight loss of more than 15% of body weight
Facility Information:
Facility Name
Başakşehir Çam Ve Sakura Hospital
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Topical Agents Containing Magnesium Sulfate & Wound Healing in the Rat Model
We'll reach out to this number within 24 hrs