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

NCT01640028 | Completed

• 1 other identifier: Inno-6026
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Oily Skin

Outcome Measures

Primary Outcomes (1)

• 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

  7 Days

Secondary Outcomes (1)

• Inter subject variability in sebum excretion rate

  7 Days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Innovaderm Research Inc.: lead

Study Sites (1)

Innovaderm Research

Montreal, Quebec, H2K 4L5, Canada

Location

Study Officials

• Robert Bissonnette, MD, FRCPC

  Innovaderm Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: July 13, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 10, 2017

Record last verified: 2017-03

Locations

CA (1)