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

Sponsor

Basaksehir Cam & Sakura Şehir Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04886882

Collaborator

Istanbul Kent University (Other)

Enrollment

Location

Arms

3.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Mar 22, 2021

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jul 1, 2021

Arms and Interventions

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

Primary Outcome Measures

7th day evaluation [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

15th day evaluation [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

Criteria

Ages Eligible for Study:

8 Weeks to 12 Weeks

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

healthy rats between ages of 8- 12 weeks

Exclusion Criteria:

weight loss of more than 15% of body weight

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Başakşehir Çam Ve Sakura Hospital	Istanbul		Turkey

Sponsors and Collaborators

Basaksehir Cam & Sakura Şehir Hospital
Istanbul Kent University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Basaksehir Cam & Sakura Şehir Hospital

ClinicalTrials.gov Identifier:

NCT04886882

Other Study ID Numbers:

SakuraDermatology1

First Posted:

May 14, 2021

Last Update Posted:

May 14, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Basaksehir Cam & Sakura Şehir Hospital

magnesium sulphate

wound healing rat model

hydroxyproline

Additional relevant MeSH terms:

Wounds and Injuries

Study Results

No Results Posted as of May 14, 2021