ScarTOP/OTOPNCT01579227
Efficacy Of Tocotrienol a Natural Vitamin E In Biopsy Wound
An observational study of Scar, run by Chandan K Sen at 1 site in United States.
Trial summary
The following two objectives are proposed in healthy subjects to characterize (1) wound closure, (2) scar formation/appearance, and (3) inflammatory response: Objective 1, (topical only - referred to as "TOP") - Topical application of Tocotrienol (TCT) vs placebo in bilateral punch biopsy Objective 2, (oral and… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Scar
- What is being tested?
- Topical Tocotrienol (TCT), Oral Tocotrienol Capsules (TCT) and Tamoxifen Cream
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2018
- Phase
- Observational
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: We plan to recruit 27 healthy adult subjects for the TOP group, 34 healthy adult subjects for the OTOP group,10 healthy adult subjects for the TAM group and 30 healthy subjects for Normal Skin.
Who may be able to join
- Ages- 18-50 (Both Male \& Female)
- Non-smoker - having quit at least 3 months prior to enrollment
- Non-diabetic
- Non-pregnant or non-breastfeeding - verbal assent.
- If a female subject of childbearing age misses her menstrual period after the start of the study, she will inform the investigators and be given a pregnancy test to ensure, for safety reasons, that she is not pregnant. If she is pregnant, she will discontinue participation in the study.
- No current use of OTC medications or other form of supplements containing vitamin-E
Who cannot join
- Diabetes or HIV diagnosis
- Alcohol or drug abuse
- unable to provide informed consent
- Therapeutically anti-coagulated
- Prisoner
- Currently prescribed immunosuppressant medication
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Efficacy Of Tocotrienol a Natural Vitamin E In Biopsy Wound.
The following two objectives are proposed in healthy subjects to characterize (1) wound closure, (2) scar formation/appearance, and (3) inflammatory response:
Objective 1, (topical only - referred to as "TOP") - Topical application of Tocotrienol (TCT) vs placebo in bilateral punch biopsy
Objective 2, (oral and topical - referred to as "OTOP") - Combined oral supplementation and topical application of tocotrienol (TCT) vs placebo in bilateral punch biopsy
Objective 3, (topical only - referred to as "TAM") - Topical application of tamoxifen vs placebo in bilateral punch biopsy.
Objective 4, (topical only to normal skin) - Topical application of TCT vs placebo on bilateral lets on normal skin.
Read the detailed description
- In nature, the vitamin E family is split into two classes: tocopherols (TCP) and tocotrienols (TCT). Members of the TCP and TCT family are biologically unique.
- TCP are mainly found in green leafy vegetables while TCT are the primary vitamin E of seeds, including cereal grains such as wheat, rice, and barley.
- Vitamin E is thought to improve wound healing by inhibiting collagen synthesis and attenuating fibroblast proliferation and inflammation. However, outcomes based scientific literature on the therapeutic efficacy of vitamin E in skin wound closure is scant and has primarily focused on TCP.
- Oral supplementation of TCP showed modest improvement in rodent wound closure, but the relevance of oral TCP supplementation in rats already receiving high dose vitamin E in a standard laboratory is questionable.
- Topical TCP on surgical wounds of children have been shown to improve wound healing; yet no mechanistic basis for the observed effect was described.
- Preliminary observations from the PI's active IRB protocol to test TCT in scar appearance of surgical wounds led us to evaluate the potential of TCT vitamin E to improve wound closure in healthy subjects. To date, the therapeutic efficacy of TCT in either topical (TOP) or oral with topical (OTOP) applications for skin wound healing remains to be reported.
- Preliminary observations also made show down-regulation of microRNA-200b supports cutaneous angiogenesis, the most important step in cutaneous wound healing. Tamoxifen silences mircroRNA-200b and later work has recognized that under non-neoplastic conditions, tamoxifen may induce angiogenesis.
- Conditions
- Scar
- Being tested
- Topical Tocotrienol (TCT), Oral Tocotrienol Capsules (TCT), Tamoxifen Cream, Placebo cream, placebo capsule
- Keywords
- Healthy participants
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Tocotrienol (TCT)Device
Also called TCT
Natural Form Vitamin E topical cream(TCT)
Oral Tocotrienol Capsules (TCT)Dietary supplement
Also called TCT
Natural Form Vitamin E Oral capsules (TCT)
Tamoxifen CreamDevice
Tamoxifen cream
Placebo creamDevice
Also called Placebo
Placebo cream
placebo capsuleDietary supplement
Also called placebo
placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| 1-TOP group 1 | TOP group 1 will have biopsy #2 collected 3 days after 1st biopsy collected. | |
| TOP group 2 | TOP group 2 will have biopsy #2 collected 30 days after 1st biopsy collected. | |
| OTOP group-1 | OTOP will use topical cream (either topical tocotrienol (TCT) or placebo cream) as well as oral supplementation (either oral Tocotrienol capsules (TCT) or placebo capsules). OTOP group 1 will have biopsy #2 collected 3 days after 1st biopsy collected. Receives: Device: Topical Tocotrienol (TCT); Dietary Supplement: Oral Tocotrienol Capsules (TCT); Device: Placebo cream; Dietary Supplement: placebo capsule | |
| OTOP group-2 | OTOP will use topical cream (either topical tocotrienol (TCT) or placebo cream) as well as oral supplementation (either oral Tocotrienol capsules (TCT) or placebo capsules). OTOP group 2 will have biopsy #2 collected 30 days after 1st biopsy collected. Receives: Device: Topical Tocotrienol (TCT); Dietary Supplement: Oral Tocotrienol Capsules (TCT); Device: Placebo cream; Dietary Supplement: placebo capsule | |
| TAM Group 1 | TAM group 1 will have #2 biopsy collected 21 days after 1st biopsy collected. Tamoxifen cream and placebo cream will be applied where biopsies are collected from 1 week prior to having the biopsy procedure until the second biopsy is collected (21 days later). Receives: Device: Tamoxifen Cream | |
| Normal Skin | Placebo group will apply placebo and TCT cream that will be applied daily to a specified area on the subjects legs (normal skin) for 5 weeks. One leg will be applied with placebo and the other will be applied with TCT cream. Subjects will return weekly for 5 weeks, where non-invasive measurements using Laser Speckle imaging, will be completed at each study visit Receives: Device: Tamoxifen Cream; Device: Placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOUND CLOSURE
Wound closure will be assessed by results of conventional camera and thermal imaging in Group 1 and Group 2 subjects.
Measured: 1-2 month(s)
Secondary outcomes (1)
SCARRING
Scarring will be assessed in group 1 and group 2 subjects by the Vancouver Scar Scale (VSS). Scoring will be performed by three blinded observers. The VSS evaluates vascularity (redness), height (hypertrophy), pliability (contracture and elastic texture) and pigmentation.
Measured: 1-2 month (s)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chandan K Sen
- Sponsor type
- University, hospital or other
- Collaborators
- Carotech Inc.
- Responsible party
- Sponsor-investigator, Chandan K Sen, Ohio State University
- Investigators
- Chandan K Sen, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579227
- Sponsor's protocol ID
- 2011H0286
- Acronym
- TOP/OTOP
- Status last verified
- Jan 2017
- First submitted
- 13 Apr 2012
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Tocotrienol a Natural Vitamin E In Biopsy Wound.
- ClinicalTrials.gov ID
- NCT01579227
- Acronym / sponsor ID
- TOP/OTOP / 2011H0286
- Conditions
- Scar
- Keywords
- Healthy participants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- Chandan K SenUniversity, hospital or other
- Collaborators
- Carotech Inc.
- Study start
- Jan 2012
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 17 Apr 2012 (estimated)
- 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.
The following two objectives are proposed in healthy subjects to characterize (1) wound closure, (2) scar formation/appearance, and (3) inflammatory response:
Objective 1, (topical only - referred to as "TOP") - Topical application of Tocotrienol (TCT) vs placebo in bilateral punch biopsy
Objective 2, (oral and topical - referred to as "OTOP") - Combined oral supplementation and topical application of tocotrienol (TCT) vs placebo in bilateral punch biopsy
Objective 3, (topical only - referred to as "TAM") - Topical application of tamoxifen vs placebo in bilateral punch biopsy.
Objective 4, (topical only to normal skin) - Topical application of TCT vs placebo on bilateral lets on normal skin.
Detailed description
- In nature, the vitamin E family is split into two classes: tocopherols (TCP) and tocotrienols (TCT). Members of the TCP and TCT family are biologically unique.
- TCP are mainly found in green leafy vegetables while TCT are the primary vitamin E of seeds, including cereal grains such as wheat, rice, and barley.
- Vitamin E is thought to improve wound healing by inhibiting collagen synthesis and attenuating fibroblast proliferation and inflammation. However, outcomes based scientific literature on the therapeutic efficacy of vitamin E in skin wound closure is scant and has primarily focused on TCP.
- Oral supplementation of TCP showed modest improvement in rodent wound closure, but the relevance of oral TCP supplementation in rats already receiving high dose vitamin E in a standard laboratory is questionable.
- Topical TCP on surgical wounds of children have been shown to improve wound healing; yet no mechanistic basis for the observed effect was described.
- Preliminary observations from the PI's active IRB protocol to test TCT in scar appearance of surgical wounds led us to evaluate the potential of TCT vitamin E to improve wound closure in healthy subjects. To date, the therapeutic efficacy of TCT in either topical (TOP) or oral with topical (OTOP) applications for skin wound healing remains to be reported.
- Preliminary observations also made show down-regulation of microRNA-200b supports cutaneous angiogenesis, the most important step in cutaneous wound healing. Tamoxifen silences mircroRNA-200b and later work has recognized that under non-neoplastic conditions, tamoxifen may induce angiogenesis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1-TOP group 1 | – | –TOP group 1 will have biopsy #2 collected 3 days after 1st biopsy collected. |
| TOP group 2 | – | –TOP group 2 will have biopsy #2 collected 30 days after 1st biopsy collected. |
| OTOP group-1 | – | Device: Topical Tocotrienol (TCT), Dietary Supplement: Oral Tocotrienol Capsules (TCT), Device: Placebo cream, Dietary Supplement: placebo capsuleOTOP will use topical cream (either topical tocotrienol (TCT) or placebo cream) as well as oral supplementation (either oral Tocotrienol capsules (TCT) or placebo capsules). OTOP group 1 will have biopsy #2 collected 3 days after 1st biopsy collected. |
| OTOP group-2 | – | Device: Topical Tocotrienol (TCT), Dietary Supplement: Oral Tocotrienol Capsules (TCT), Device: Placebo cream, Dietary Supplement: placebo capsuleOTOP will use topical cream (either topical tocotrienol (TCT) or placebo cream) as well as oral supplementation (either oral Tocotrienol capsules (TCT) or placebo capsules). OTOP group 2 will have biopsy #2 collected 30 days after 1st biopsy collected. |
| TAM Group 1 | – | Device: Tamoxifen CreamTAM group 1 will have #2 biopsy collected 21 days after 1st biopsy collected. Tamoxifen cream and placebo cream will be applied where biopsies are collected from 1 week prior to having the biopsy procedure until the second biopsy is collected (21 days later). |
| Normal Skin | – | Device: Tamoxifen Cream, Device: Placebo creamPlacebo group will apply placebo and TCT cream that will be applied daily to a specified area on the subjects legs (normal skin) for 5 weeks. One leg will be applied with placebo and the other will be applied with TCT cream. Subjects will return weekly for 5 weeks, where non-invasive measurements using Laser Speckle imaging, will be completed at each study visit |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- We plan to recruit 27 healthy adult subjects for the TOP group, 34 healthy adult subjects for the OTOP group,10 healthy adult subjects for the TAM group and 30 healthy subjects for Normal Skin.
Key inclusion criteria (6 listed)
- Ages- 18-50 (Both Male \& Female)
- Non-smoker - having quit at least 3 months prior to enrollment
- Non-diabetic
- Non-pregnant or non-breastfeeding - verbal assent.
- If a female subject of childbearing age misses her menstrual period after the start of the study, she will inform the investigators and be given a pregnancy test to ensure, for safety reasons, that she is not pregnant. If she is pregnant, she will discontinue participation in the study.
Key exclusion criteria (6 listed)
- Diabetes or HIV diagnosis
- Alcohol or drug abuse
- unable to provide informed consent
- Therapeutically anti-coagulated
- Prisoner
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 |
|---|---|---|
| Topical Tocotrienol (TCT)Also: TCTNatural Form Vitamin E topical cream(TCT) | Device | OTOP group-1, OTOP group-2 |
| Oral Tocotrienol Capsules (TCT)Also: TCTNatural Form Vitamin E Oral capsules (TCT) | Dietary supplement | OTOP group-1, OTOP group-2 |
| Tamoxifen CreamTamoxifen cream | Device | Normal Skin, TAM Group 1 |
| Placebo creamAlso: PlaceboPlacebo cream | Device | Normal Skin, OTOP group-1, OTOP group-2 |
| placebo capsuleAlso: placeboplacebo capsule | Dietary supplement | OTOP group-1, OTOP group-2 |
Primary outcome
WOUND CLOSURE
Time frame: 1-2 month(s)
Wound closure will be assessed by results of conventional camera and thermal imaging in Group 1 and Group 2 subjects.
1 secondary outcome
SCARRING
Time frame: 1-2 month (s)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
Related trials for Scar
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
RecruitingPhase 2
Tirzepatide for Treatment of CCCA
Central Centrifugal Cicatricial Alopecia (CCCA)
Recruiting
Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement
Skin Graft Scar
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.
Chandan K Sen, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scar, run by Chandan K Sen at 1 site in United States.
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 6 inclusion and 6 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 29 Jan 2018. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
WOUND CLOSURE (time frame: 1-2 month(s)). 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 29 Jan 2018.