Wound HealEarly Phase 1NCT04886882
Topical Agents Containing Magnesium Sulfate & Wound Healing in the Rat Model
A Early Phase 1 study testing Experimental drug 1, Experimental drug 2 and Centella asiatica in people with Wound Heal, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
An experimental study examining wound healing in 5 different groups on 30 rats. Read more about this study
- Who is it for?
- Ages 8 to 12 weeks, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wound Heal
- What is being tested?
- Experimental drug 1, Experimental drug 2 and Centella asiatica
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Mar 2021to 1 Jul 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 weeks
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy rats between ages of 8- 12 weeks
Who cannot join
- weight loss of more than 15% of body weight
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Topical Agents in Cream Formations Containing Magnesium Sulfate on Wound Healing in the Rat Model
An experimental study examining wound healing in 5 different groups on 30 rats.
Read the 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.
- Conditions
- Wound Heal
- Being tested
- placebo comparator, sham comparator, Experimental drug 1, Experimental drug 2, Centella asiatica
- Keywords
- magnesium sulphate, wound healing rat model, hydroxyproline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo comparatorOther
solution containing 0.9 % sodium chlorine
sham comparatorOther
vaseline, beeswax,polyglyceryl-3 diisostearate, sorbitan caprylate, propandiol,benzoic acid, glycerin, water
Experimental drug 1Other
A cream containing 10 % MgSO4.vaseline, beeswaxpolyglyceryl-3 diisostearate, sorbitan caprylate, propandiol,benzoic acid, glycerin, water
Experimental drug 2Other
A cream containing 10 % MgSO4.vaseline, beeswax,polyglyceryl-3 diisostearate, sorbitan caprylate, propandiol,benzoic acid, glycerin, water
Centella asiaticaDrug
A cream containing Centella asiatica
| Study group | Role | What they receive |
|---|---|---|
| Group placebo | Placebo comparator | Isotonic solution will be administered daily to 6 female rats. Receives: Other: placebo comparator |
| Group sham | Sham comparator | Base cream to be applied twice a day to 6 female rats. Receives: Other: sham comparator |
| Group %1 mgso4 | Experimental | Cream containing 1% MgSO4 will be applied twice a day to 6 female rats. Receives: Other: Experimental drug 1 |
| Group %10 MgSO4 | Experimental | Cream containing 10% MgSO4 will be applied twice a day to 6 female rats. Receives: Other: Experimental drug 2 |
| Group positive control | Active comparator | Cream containing centella asiatica will be applied twice a day to 6 female rats. Receives: Drug: Centella asiatica |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7th day
Secondary outcomes (1)
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.
Measured: 15th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start22 Mar 2021
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Collaborators
- Istanbul Kent University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886882
- Sponsor's protocol ID
- SakuraDermatology1
- Status last verified
- Apr 2021
- First submitted
- 13 Apr 2021
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Topical Agents in Cream Formations Containing Magnesium Sulfate on Wound Healing in the Rat Model
- ClinicalTrials.gov ID
- NCT04886882
- Acronym / sponsor ID
- SakuraDermatology1
- Conditions
- Wound Heal
- Keywords
- magnesium sulphate, wound healing rat model, hydroxyproline
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Collaborators
- Istanbul Kent University
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group placebo | Placebo comparator | Other: placebo comparatorIsotonic solution will be administered daily to 6 female rats. |
| Group sham | Sham comparator | Other: sham comparatorBase cream to be applied twice a day to 6 female rats. |
| Group %1 mgso4 | Experimental | Other: Experimental drug 1Cream containing 1% MgSO4 will be applied twice a day to 6 female rats. |
| Group %10 MgSO4 | Experimental | Other: Experimental drug 2Cream containing 10% MgSO4 will be applied twice a day to 6 female rats. |
| Group positive control | Active comparator | Drug: Centella asiaticaCream containing centella asiatica will be applied twice a day to 6 female rats. |
Who may qualify
- Ages
- 8 to 12 weeks
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy rats between ages of 8- 12 weeks
Key exclusion criteria (1 listed)
- weight loss of more than 15% of body weight
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebo comparatorsolution containing 0.9 % sodium chlorine | Other | Group placebo |
| sham comparatorvaseline, beeswax,polyglyceryl-3 diisostearate, sorbitan caprylate, propandiol,benzoic acid, glycerin, water | Other | Group sham |
| Experimental drug 1A cream containing 10 % MgSO4.vaseline, beeswaxpolyglyceryl-3 diisostearate, sorbitan caprylate, propandiol,benzoic acid, glycerin, water | Other | Group %1 mgso4 |
| Experimental drug 2A cream containing 10 % MgSO4.vaseline, beeswax,polyglyceryl-3 diisostearate, sorbitan caprylate, propandiol,benzoic acid, glycerin, water | Other | Group %10 MgSO4 |
| Centella asiaticaA cream containing Centella asiatica | Drug | Group positive control |
Primary outcome
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.
1 secondary outcome
15th day evaluation
Time frame: 15th day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Experimental drug 1, Experimental drug 2 and Centella asiatica in people with Wound Heal, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7th day evaluation (time frame: 7th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.