Oily Skin Clinical Trial
Official title:
Exploratory Study of Intra and Inter-subject Variability in Sebum Excretion Rate
Verified date | March 2017 |
Source | Innovaderm Research Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | December 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Innovaderm Research | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Innovaderm Research Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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-a-reductase type 1, diet, UV exposure and sleep patterns | 7 Days | |
Secondary | 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-a-reductase type 1, diet, UV exposure and sleep patterns | 7 Days |
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