The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Topical Agents Containing Magnesium Sulfate & Wound Healing in the Rat Model

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04886882
Recruitment Status : Unknown
Verified April 2021 by Başakşehir Çam & Sakura City Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : May 14, 2021
Last Update Posted : May 14, 2021
Sponsor:
Collaborator:
Istanbul Kent University
Information provided by (Responsible Party):
Başakşehir Çam & Sakura City Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
An experimental study examining wound healing in 5 different groups on 30 rats.

Condition or disease Intervention/treatment Phase
Wound Heal Other: placebo comparator Other: sham comparator Other: Experimental drug 1 Other: Experimental drug 2 Drug: Centella asiatica Early Phase 1

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: The Effect of Topical Agents in Cream Formations Containing Magnesium Sulfate on Wound Healing in the Rat Model
Actual Study Start Date : March 22, 2021
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: Group placebo
Isotonic solution will be administered daily to 6 female rats.
 Other: placebo comparator
solution containing 0.9 % sodium chlorine
Sham Comparator: Group sham
Base cream to be applied twice a day to 6 female rats.
 Other: sham comparator
vaseline, beeswax,polyglyceryl-3 diisostearate, sorbitan caprylate, propandiol,benzoic acid, glycerin, water
Experimental: Group %1 mgso4
Cream containing 1% MgSO4 will be applied twice a day to 6 female rats.
 Other: Experimental drug 1
A cream containing 10 % MgSO4.vaseline, beeswaxpolyglyceryl-3 diisostearate, sorbitan caprylate, propandiol,benzoic acid, glycerin, water
Experimental: Group %10 MgSO4
Cream containing 10% MgSO4 will be applied twice a day to 6 female rats.
 Other: Experimental drug 2
A cream containing 10 % MgSO4.vaseline, beeswax,polyglyceryl-3 diisostearate, sorbitan caprylate, propandiol,benzoic acid, glycerin, water
Active Comparator: Group positive control
Cream containing centella asiatica will be applied twice a day to 6 female rats.
 Drug: Centella asiatica
A cream containing Centella asiatica


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 7th day evaluation [ Time Frame: 7th day ]
    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 :
  1. 15th day evaluation [ Time Frame: 15th day ]
    Histopathological evaluation of wound healing comparing with the rate of VEGF, TGF-beta and hydroxyproline at immunohistochemical staining with biopsy on the 15th day.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy rats between ages of 8- 12 weeks

Exclusion Criteria:

  • weight loss of more than 15% of body weight
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04886882


Locations
Layout table for location information
Turkey
Başakşehir Çam Ve Sakura Hospital
Istanbul, Turkey
Sponsors and Collaborators
Başakşehir Çam & Sakura City Hospital
Istanbul Kent University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Başakşehir Çam & Sakura City Hospital
ClinicalTrials.gov Identifier: NCT04886882    
Other Study ID Numbers: SakuraDermatology1
First Posted: May 14, 2021    Key Record Dates
Last Update Posted: May 14, 2021
Last Verified: April 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Başakşehir Çam & Sakura City Hospital:
magnesium sulphate
wound healing rat model
hydroxyproline
Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries