ScarsNCT01504061
Mederma to Reduce Appearance of Post Surgical Scars
A study testing Mederma N&I and Mederma Ultra Gel in people with Scars, run by Merz North America, Inc. at 1 site in United States.
Trial summary
This is a single-center, 20-subject, investigator-blinded study to evaluate the effect of Mederma N\&I to Mederma Ultra Gel on the appearance of post-surgical scars. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Scars
- What is being tested?
- Mederma N&I and Mederma Ultra Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Aug 2012
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be 18-70 years of age, of any race or sex.
- Subjects must be Fitzpatrick skin type I-VI.
- Subjects must have two symmetrical upper chest and/or back seborrheic keratoses and in the opinion of the investigator are good candidates for the study.
Who cannot join
- Subjects with known allergies or sensitivities to ingredients contained in the test product including onion extract and Lidocaine.
- Subjects with known history of keloids or hypertrophic scars.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC
Charlotte, North Carolina, 28207
About this study
Official title: The Comparison of Mederma® N&I to Mederma® Ultra Gel to Reduce the Appearance of Post Surgical Scars
This is a single-center, 20-subject, investigator-blinded study to evaluate the effect of Mederma N\&I to Mederma Ultra Gel on the appearance of post-surgical scars.
Read the detailed description
This is a 10-week research study designed to compare the effect of two gels on the appearance of post surgical scarring of the chest and/or back. The subject will be asked to identify two symmetrical skin growths that they would like to have removed: one on the left chest and/or back and one on the right chest and/or back. Additionally, the subject will identify a third skin growth that they would like removed which is a reasonable distance from the two symmetrical skin growths and will be located either on the back or the chest.
Inclusion Criteria:
- Healthy male and non pregnant female subjects ≥18 years of age
- have seborrheic keratoses on the right and left chest and/or back
Exclusion Criteria:
-Subjects with known allergies or sensitivities to ingredients contained in the test product including onion extract and Lidocaine.
- Conditions
- Scars
- Being tested
- Mederma N&I, Mederma Ultra Gel
- Keywords
- surgical, scars, Mederma
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mederma N&IOther
Topical gel applied three times a day for eight weeks.
Mederma Ultra GelOther
Topical gel applied once daily for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mederma Ultra Gel | Experimental | Not described Receives: Other: Mederma Ultra Gel |
| Mederma N&I | Active comparator | Not described Receives: Other: Mederma N&I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator assessment of post-surgical scar appearance (indices are erythema, softness, texture, and overall appearance). This assessment is accompanied by photography and dermaspectrophotometry.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarsStudies 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
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Girish Munavalli, MD, MHS, Principal investigator, Dermatology, Laser, and Vein Specialists of Carolinas, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504061
- Sponsor's protocol ID
- MUS90025-4007-0
- Status last verified
- Oct 2013
- First submitted
- 6 Dec 2011
- Last updated
- 24 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Mederma® N&I to Mederma® Ultra Gel to Reduce the Appearance of Post Surgical Scars
- ClinicalTrials.gov ID
- NCT01504061
- Acronym / sponsor ID
- MUS90025-4007-0
- Conditions
- Scars
- Keywords
- surgical, scars, Mederma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 5 Jan 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.
This is a single-center, 20-subject, investigator-blinded study to evaluate the effect of Mederma N\&I to Mederma Ultra Gel on the appearance of post-surgical scars.
Detailed description
This is a 10-week research study designed to compare the effect of two gels on the appearance of post surgical scarring of the chest and/or back. The subject will be asked to identify two symmetrical skin growths that they would like to have removed: one on the left chest and/or back and one on the right chest and/or back. Additionally, the subject will identify a third skin growth that they would like removed which is a reasonable distance from the two symmetrical skin growths and will be located either on the back or the chest.
Inclusion Criteria:
- Healthy male and non pregnant female subjects ≥18 years of age
- have seborrheic keratoses on the right and left chest and/or back
Exclusion Criteria:
-Subjects with known allergies or sensitivities to ingredients contained in the test product including onion extract and Lidocaine.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mederma Ultra Gel | Experimental | Other: Mederma Ultra Gel |
| Mederma N&I | Active comparator | Other: Mederma N&I |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must be 18-70 years of age, of any race or sex.
- Subjects must be Fitzpatrick skin type I-VI.
- Subjects must have two symmetrical upper chest and/or back seborrheic keratoses and in the opinion of the investigator are good candidates for the study.
Key exclusion criteria (2 listed)
- Subjects with known allergies or sensitivities to ingredients contained in the test product including onion extract and Lidocaine.
- Subjects with known history of keloids or hypertrophic scars.
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 |
|---|---|---|
| Mederma N&ITopical gel applied three times a day for eight weeks. | Other | Mederma N&I |
| Mederma Ultra GelTopical gel applied once daily for eight weeks. | Other | Mederma Ultra Gel |
Primary outcome
Investigator assessment of post-surgical scar appearance (indices are erythema, softness, texture, and overall appearance). This assessment is accompanied by photography and dermaspectrophotometry.
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2013.
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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.
Girish Munavalli, MD, MHS principal investigator
Dermatology, Laser, and Vein Specialists of Carolinas, PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mederma N&I and Mederma Ultra Gel in people with Scars, run by Merz North America, Inc. 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 24 Oct 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Investigator assessment of post-surgical scar appearance (indices are erythema, softness, texture, and overall appearance). This assessment is accompanied by photography and dermaspectrophotometry. (time frame: 10 weeks). 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 24 Oct 2013.