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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 March 2013 |
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Main ID: |
NCT01212172 |
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Date of registration:
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22/09/2010 |
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Primary sponsor: |
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Public title:
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Comparison of Efficacy, Safety and Tolerability of Two Different 810 nm Diode Lasers for Hair Reduction
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Scientific title:
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Side-by-Side Comparison of 810 nm Diode Laser Technology With Low Fluence-High Repetition Rate vs Low Fluence-Vacuum Assist - A Split - Extremity Efficacy , Safety and Tolerability Study |
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Date of first enrolment:
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September 2010 |
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Target sample size:
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30 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01212172 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Christopher B Zachary, MBBS, FRCP |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, Irvine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Subjects must be at least 18 years of age.
2. Subjects must be in reasonably good health as defined by the Investigator.
3. Subject agrees to avoid tanning during their participation in this trial.
4. Subject has Fitzpatrick skin types I-V and dark brown hair.
5. Subjects must agree to avoid shaving legs less than 72 hours prior to a study visit.
6. Subjects have indicated willingness to participate in the study by signing an
informed consent document.
Exclusion Criteria:
1. Subject is pregnant, lactating, or planning to get pregnant within the study period.
2. Subject is unwilling to use birth control during the study period if of child bearing
age.
3. Subject has a known history of photosensitivity or use of medication with
photosensitizing properties.
4. Subject has skin disease on exam at screening.
5. Subject has history or evidence of any chronic or reoccurring skin disease or
disorder(e.g., psoriasis, Netherton syndrome, etc.) affecting the treatment area.
6. Subject has a history of keloid or hypertrophic scar formation.
7. Subject has a tattoo in the treatment area.
8. Subject has been tanning within the past 30 days.
9. Subject has history of confounding cancerous or pre-cancerous skin lesions in the
treatment area.
10. Subject has used prohibited therapies (electrolysis, threading, waxing, depilatory),
prohibited oral prescription medications (isotretinoin, steroids), or prohibited
topical meds (steroids) on the treatment area within 30 days prior to enrollment.
11. Subject is unwilling to discontinue use of above listed prohibitive therapies for the
duration of treatment.
12. Subject has a history of laser hair removal in the treatment area.
13. Subject has participated in any clinical trial involving an investigational drug or
cosmetic product or procedure within the past 30 days.
14. The investigator feels that for any reason the subject is not eligible to participate
in the study.
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Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hair Removal
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Intervention(s)
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Device: LightSheer
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Device: Soprano/SHR
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Primary Outcome(s)
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Reduction in hair growth
[Time Frame: 12 months]
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Secondary Outcome(s)
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Hair follicle histology
[Time Frame: Skin biopsy of treatment area taken at 24 hr after the. 1st and 5th treatment.]
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Reduction in hair density
[Time Frame: 12 months]
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Secondary ID(s)
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2010-7704
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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