Exploratory Study of Intra and Inter-subject Variability in Sebum Excretion Rate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Innovaderm Research Inc.
ClinicalTrials.gov Identifier:
NCT01640028
First received: July 11, 2012
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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.


Condition
Oily Skin.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Exploratory Study of Intra and Inter-subject Variability in Sebum Excretion Rate

Further study details as provided by Innovaderm Research Inc.:

Primary Outcome Measures:
  • Intra subject variability of sebum excretion rate [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Inter subject variability in sebum excretion rate [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
    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


Enrollment: 41
Study Start Date: July 2012
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  1. Subject has a sebum excretion rate of at least 4 at Day 0 on both sides of the forehead as measured with Sebutape.
  2. Subject is 18 years of age or older at time of consent and is in generally good health.
  3. 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:

    1. Barrier methods such as condom, sponge or diaphragm combined with spermicide in foam, gel or cream;
    2. Hormonal contraception (oral, intramuscular, implant or transdermal) which include Depo-Provera, Evra and Nuvaring;
    3. Intrauterine device (IUD);
    4. Sterilization such as tubal ligation, oophorectomy, hysterectomy or vasectomized partner;
    5. Postmenopausal state for at least 1 year for female subject or female partner of male subject;
    6. Same-sex partner;
    7. Abstinence.
  4. Subject has a negative urine pregnancy test at Day 0 visit for female subject of childbearing potential only.
  5. Subject is capable of giving informed consent and the consent must be obtained prior to any study related procedures.

Exclusion Criteria:

  1. Subject is currently pregnant or lactating.
  2. Subject has any skin condition on the forehead that could interfere with sebum excretion measurement except for mild acne vulgaris.
  3. 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.
  4. Subject has used any topical medication on the face within 14 days of Day 0 or plans to during the study.
  5. Subject has applied cosmetics or emollients on the forehead the morning of Day 0 visit or plans to the morning of Day 7 visit.
  6. 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.
  7. Subject has used isotretinoin in the 52 weeks preceding Day 0 or plans to during the study.
  8. 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.
  9. Known hypersensitivity/allergy to lidocaine
  10. The subject has a history of keloids
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01640028

Locations
Canada, Quebec
Innovaderm Research
Montreal, Quebec, Canada, H2K 4L5
Sponsors and Collaborators
Innovaderm Research Inc.
Investigators
Principal Investigator: Robert Bissonnette, MD, FRCPC Innovaderm Research
  More Information

No publications provided

Responsible Party: Innovaderm Research Inc.
ClinicalTrials.gov Identifier: NCT01640028     History of Changes
Other Study ID Numbers: Inno-6026
Study First Received: July 11, 2012
Last Updated: January 15, 2013
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on October 01, 2014