Oily SkinNCT01640028
Exploratory Study of Intra and Inter-subject Variability in Sebum Excretion Rate
An observational study of Oily Skin, run by Innovaderm Research Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to analyze the relationship between sebum excretion rate and the following factors: Hormone levels (testosterone, dehydroepiandrosterone sulfate) Expression of 5-α-reductase type 1 (a protein in sebaceous glands that transforms a hormone (testosterone) into another one that strongly… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oily Skin
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2012to Dec 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Approximately 40 subjects, male or female, aged 18 years or older with a sebum excretion rate (SER) of at least 4 at Day 0 on both sides of the forehead as measured with Sebutape, will be included in this study.
Who may be able to join
- Subject has a sebum excretion rate of at least 4 at Day 0 on both sides of the forehead as measured with Sebutape.
- Subject is 18 years of age or older at time of consent and is in generally good health.
- Female subject is willing to use effective contraceptive method for at least 30 days before Day 0 and until the end of the study. Effective contraceptive methods are:
- Barrier methods such as condom, sponge or diaphragm combined with spermicide in foam, gel or cream;
- Hormonal contraception (oral, intramuscular, implant or transdermal) which include Depo-Provera, Evra and Nuvaring;
- Intrauterine device (IUD);
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- Sterilization such as tubal ligation, oophorectomy, hysterectomy or vasectomized partner;
- Postmenopausal state for at least 1 year for female subject or female partner of male subject;
- Same-sex partner;
- Abstinence.
- Subject has a negative urine pregnancy test at Day 0 visit for female subject of childbearing potential only.
- Subject is capable of giving informed consent and the consent must be obtained prior to any study related procedures.
Who cannot join
- Subject is currently pregnant or lactating.
- Subject has any skin condition on the forehead that could interfere with sebum excretion measurement except for mild acne vulgaris.
- Subject has received investigational drugs within the 28 days or 5 half-lives, whichever is longer, prior to Day 0 or plans to during the study period.
- Subject has used any topical medication on the face within 14 days of Day 0 or plans to during the study.
- Subject has applied cosmetics or emollients on the forehead the morning of Day 0 visit or plans to the morning of Day 7 visit.
- At the investigator's discretion subject has current or history of alcohol or drug abuse that would interfere with the ability of the subject to comply with the study protocol.
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- Subject has used isotretinoin in the 52 weeks preceding Day 0 or plans to during the study.
- Subject should not have swum in chlorinated water within 24 hours of the Day 0 visit or plans to within 24 hours of the Day 7 visit.
- Known hypersensitivity/allergy to lidocaine
- The subject has a history of keloids
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to analyze the relationship between sebum excretion rate and the following factors:
- Hormone levels (testosterone, dehydroepiandrosterone sulfate)
- Expression of 5-α-reductase type 1 (a protein in sebaceous glands that transforms a hormone (testosterone) into another one that strongly stimulates sebum production)
- Diet
- Sun and ultraviolet light exposure.
- Facial washing routine
- Sleep patterns (time when you start sleeping and total sleep time)
This study will analyze the relationship between sebum excretion rate and the various factors that may influence it in approximately 40 subjects. It will be conducted in one center located in Montreal. All devices are known and have already been used in the past.
Read the detailed description
A total of 40 subjects with a sebum excretion rate of at least 4 will be included. Subjects will be seen at Day 0 and Day 7. Casual sebum measurements will be performed at least 2 hours after washing the face in the morning with a Sebumeter® following a 30-second application of a Sebumeter® Measurement Cartridge to the forehead. Sebum excretion rates will be measured with Sebutape® applied to the right and left forehead at each visit. Each Sebutape® will be scanned and the area covered by sebum, seen as gray-black dots on the scanned Sebutape®, will be measured by an image analysis software. Circulating levels of free testosterone and DHEAS will be measured at each visit. A skin biopsy behind an ear will be performed at Day 0 and Day 7 to measure gene expression of the 5-α-reductase type 1. On Day 0 and Day 7, subjects will be required to take a 24-hour recall questionnaire. On Day 0 and Day 7, subjects will be questioned about the time of sleep induction, their total sleep time for the night preceding the visit, facial washing routine and the number of hours of direct and indirect UV exposure in the past 24 hours. On Day 0 and Day 7, subject's forehead skin temperature will be measured.
- Conditions
- Oily Skin
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra subject variability of sebum excretion rate
To study the relationship between intra-subject variability in sebum excretion rate and androgen levels, expression of 5-α-reductase type 1, diet, UV exposure and sleep patterns
Measured: 7 Days
Secondary outcomes (1)
Inter subject variability in sebum excretion rate
To study the relationship between inter-subject variability in sebum excretion rate and androgen levels, expression of 5-α-reductase type 1, diet, UV exposure and sleep patterns
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oily SkinStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovaderm Research Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Bissonnette, MD, FRCPC, Principal investigator, Innovaderm Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640028
- Sponsor's protocol ID
- Inno-6026
- Status last verified
- Mar 2017
- First submitted
- 11 Jul 2012
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Intra and Inter-subject Variability in Sebum Excretion Rate
- ClinicalTrials.gov ID
- NCT01640028
- Acronym / sponsor ID
- Inno-6026
- Conditions
- Oily Skin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Innovaderm Research Inc.University, hospital or other
- Study start
- Jul 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Jul 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 purpose of this study is to analyze the relationship between sebum excretion rate and the following factors:
- Hormone levels (testosterone, dehydroepiandrosterone sulfate)
- Expression of 5-α-reductase type 1 (a protein in sebaceous glands that transforms a hormone (testosterone) into another one that strongly stimulates sebum production)
- Diet
- Sun and ultraviolet light exposure.
- Facial washing routine
- Sleep patterns (time when you start sleeping and total sleep time)
This study will analyze the relationship between sebum excretion rate and the various factors that may influence it in approximately 40 subjects. It will be conducted in one center located in Montreal. All devices are known and have already been used in the past.
Detailed description
A total of 40 subjects with a sebum excretion rate of at least 4 will be included. Subjects will be seen at Day 0 and Day 7. Casual sebum measurements will be performed at least 2 hours after washing the face in the morning with a Sebumeter® following a 30-second application of a Sebumeter® Measurement Cartridge to the forehead. Sebum excretion rates will be measured with Sebutape® applied to the right and left forehead at each visit. Each Sebutape® will be scanned and the area covered by sebum, seen as gray-black dots on the scanned Sebutape®, will be measured by an image analysis software. Circulating levels of free testosterone and DHEAS will be measured at each visit. A skin biopsy behind an ear will be performed at Day 0 and Day 7 to measure gene expression of the 5-α-reductase type 1. On Day 0 and Day 7, subjects will be required to take a 24-hour recall questionnaire. On Day 0 and Day 7, subjects will be questioned about the time of sleep induction, their total sleep time for the night preceding the visit, facial washing routine and the number of hours of direct and indirect UV exposure in the past 24 hours. On Day 0 and Day 7, subject's forehead skin temperature will be measured.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 40 subjects, male or female, aged 18 years or older with a sebum excretion rate (SER) of at least 4 at Day 0 on both sides of the forehead as measured with Sebutape, will be included in this study.
Key inclusion criteria (12 listed)
- Subject has a sebum excretion rate of at least 4 at Day 0 on both sides of the forehead as measured with Sebutape.
- Subject is 18 years of age or older at time of consent and is in generally good health.
- Female subject is willing to use effective contraceptive method for at least 30 days before Day 0 and until the end of the study. Effective contraceptive methods are:
- Subject has a negative urine pregnancy test at Day 0 visit for female subject of childbearing potential only.
- Subject is capable of giving informed consent and the consent must be obtained prior to any study related procedures.
Key exclusion criteria (10 listed)
- Subject is currently pregnant or lactating.
- Subject has any skin condition on the forehead that could interfere with sebum excretion measurement except for mild acne vulgaris.
- Subject has received investigational drugs within the 28 days or 5 half-lives, whichever is longer, prior to Day 0 or plans to during the study period.
- Subject has used any topical medication on the face within 14 days of Day 0 or plans to during the study.
- Subject has applied cosmetics or emollients on the forehead the morning of Day 0 visit or plans to the morning of Day 7 visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intra subject variability of sebum excretion rate
Time frame: 7 Days
To study the relationship between intra-subject variability in sebum excretion rate and androgen levels, expression of 5-α-reductase type 1, diet, UV exposure and sleep patterns
1 secondary outcome
Inter subject variability in sebum excretion rate
Time frame: 7 Days
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 10 Mar 2017.
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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.
Robert Bissonnette, MD, FRCPC principal investigator
Innovaderm Research
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 Oily Skin, run by Innovaderm Research Inc. at 1 site in Canada.
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 12 inclusion and 10 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 10 Mar 2017. 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 Canada. 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?
Intra subject variability of sebum excretion rate (time frame: 7 Days). 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 10 Mar 2017.