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

NCT04886882 — Early Phase 1, Unknown, 30 participants, Başakşehir Çam & Sakura City Hospital

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The Effect of Topical Agents in Cream Formations Containing Magnesium Sulfate on Wound Healing in the Rat Model

Registry	NCT04886882
Status	Unknown
Phase	Early Phase 1
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	30 (Estimated)
Sponsor	Başakşehir Çam & Sakura City Hospital (Other gov); collaborators: Istanbul Kent University
Conditions	Wound Heal
Interventions	placebo comparator, sham comparator, Experimental drug 1, Experimental drug 2, Centella asiatica (Other, drug)
Dates	start 2021-03-22, primary completion 2021-06-01 (estimated), completion 2021-07-01 (estimated), first posted 2021-05-14, last updated 2021-05-14
Locations	1 site in Turkey (Türkiye)

-Summary

An experimental study examining wound healing in 5 different groups on 30 rats.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Group placebo	Placebo comparator	Other: placebo comparator	Isotonic solution will be administered daily to 6 female rats.
Group sham	Sham comparator	Other: sham comparator	Base cream to be applied twice a day to 6 female rats.
Group %1 mgso4	Experimental	Other: Experimental drug 1	Cream containing 1% MgSO4 will be applied twice a day to 6 female rats.
Group %10 MgSO4	Experimental	Other: Experimental drug 2	Cream containing 10% MgSO4 will be applied twice a day to 6 female rats.
Group positive control	Active comparator	Drug: Centella asiatica	Cream containing centella asiatica will be applied twice a day to 6 female rats.

placebo comparator (Other): solution containing 0.9 % sodium chlorine
sham comparator (Other): vaseline, beeswax,polyglyceryl-3 diisostearate, sorbitan caprylate, propandiol,benzoic acid, glycerin, water
Experimental drug 1 (Other): A cream containing 10 % MgSO4.vaseline, beeswaxpolyglyceryl-3 diisostearate, sorbitan caprylate, propandiol,benzoic acid, glycerin, water
Experimental drug 2 (Other): A cream containing 10 % MgSO4.vaseline, beeswax,polyglyceryl-3 diisostearate, sorbitan caprylate, propandiol,benzoic acid, glycerin, water
Centella asiatica (Drug): A cream containing Centella asiatica

+Outcome measures

Primary outcomes

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 outcomes

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

Sex: Female, ages: 8 Weeks to 12 Weeks, accepts healthy volunteers

Inclusion Criteria:

* healthy rats between ages of 8- 12 weeks

Exclusion Criteria:

* weight loss of more than 15% of body weight

+Locations (1)

Facility	City	Country	Status
Başakşehir Çam Ve Sakura Hospital	Istanbul	Turkey (Türkiye)