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Pilot Study of a Novel IPL for Removal of Unwanted Fine Body Hair

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ClinicalTrials.gov Identifier: NCT01912950
Recruitment Status : Completed
First Posted : July 31, 2013
Last Update Posted : September 11, 2015
Sponsor:
Information provided by (Responsible Party):
Cutera Inc.

Brief Summary:

The purpose of this randomized, controlled, open-label pilot study is to evaluate the safety and efficacy of a novel intense pulsed light (IPL) device for removal of unwanted fine body hair.

Subjects will have a designated treatment area on one forearm divided into four equal-size quadrants. One quadrant will serve as the un-treated control area and the other 3 quadrants will be treated with the Cutera Prowave LX IPL. Subjects will receive 3 IPL treatments, spaced 8 weeks apart, on the designated area and will be followed at 12-weeks post-final treatment.


Condition or disease Intervention/treatment Phase
Hypertrichosis Device: Prowave LX IPL Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Controlled, Open-Label Pilot Study of a Novel IPL for Removal of Unwanted Fine Hair
Study Start Date : December 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Arm Intervention/treatment
Experimental: Prowave LX IPL
Prowave LX IPL, "short pulse" setting and snowflake mode "On"
Device: Prowave LX IPL
Other Names:
  • Prowave
  • Prowave LX
  • Cutera Prowave LX
  • Intense Pulsed Light
  • IPL
  • Flashlamp Infared device
  • Hair removal

No Intervention: No Treatment
No treatment administered.



Primary Outcome Measures :
  1. Change from Baseline in Quantitative Hair Count at 12-weeks post-final treatment. [ Time Frame: 12-weeks post-final treatment ]

Secondary Outcome Measures :
  1. Change from Baseline in Quantitative Hair Count at 8-weeks and 16-weeks. [ Time Frame: 8 weeks and 16 weeks ]
  2. Percent Hair Reduction at 12-weeks post-final treatment as compared to Baseline [ Time Frame: 12-weeks post-final treatment ]
  3. Average Subject Satisfaction Score [ Time Frame: 12-weeks post-final treatment ]
    Subjects will be asked to complete a questionnaire about the subject's satisfaction with the treatment results.

  4. Average Subject Discomfort during Treatment [ Time Frame: Day 0, 8 weeks and 16 weeks ]
    Subjects will be asked to rate the discomfort experienced during hair removal treatments using a 0 to 10 numeric scale.

  5. Number of Participants with Adverse Device Effects [ Time Frame: 12-weeks post final treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female or Male, 18 to 65 years of age (inclusive).
  • Fitzpatrick Skin Type I - III.
  • Subject has black or dark brown unwanted arm hair of fine texture.
  • Willing to have the hair removal procedure on one forearm only, and within the designated study treatment area.
  • Willing and able to adhere to the treatment and follow-up schedule, and the study "Before and After Procedure Instructions".
  • Willing to refrain from shaving the treatment area for 5 days prior to each study visit.
  • Must be able to read, understand and sign the Informed Consent Form.
  • Must agree not to use hair removal products, such as topical chemical depilatories, or undergo any other hair removal procedure during the study, such as other laser and light therapies or waxing.
  • Willing to refrain from excess sun exposure and willing to wear sunscreen on the treatment area during the study (including the follow-up period).
  • Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
  • Must be in good health, as determined by the Investigator.
  • Must be post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.

Exclusion Criteria:

  • Participation in a clinical trial of another device or drug within 6 months prior to enrollment, or during the study.
  • Had any type of professional hair removal procedure, such as laser, light-based, RF or electrolysis, in the treatment area within 12 months of study participation.
  • Had other epilation treatment, such as waxing or mechanical epilator, in the treatment area within 6 months of study participation.
  • Subject shows signs of actinic bronzing or recent tanning in the treatment area, and unable/unlikely to refrain from tanning during the study.
  • Subject is pregnant and/or breastfeeding.
  • Suffering from significant concurrent illness, such as diabetes mellitus or pertinent neurological disorders.
  • Having malignant or pre-malignant lesions in the treatment area, or history of a malignant skin disease.
  • Current acute or chronic skin infections or inflammatory processes, affecting the treatment area, such as dermatitis.
  • Currently using immunosuppressive medications or history of immunosuppression/immune deficiency disorder, such as psoriasis, eczema, vitiligo, systemic lupus erythematosus or scleroderma.
  • Current use of any medication that is known to increase sensitivity to light, such as tetracycline.
  • Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment within 3 months of study participation.
  • Suffering from coagulation disorders or taking prescription anticoagulation medications.
  • History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing.
  • History of seizure disorders due to light.
  • History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen.
  • History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
  • History of tattoo, permanent make-up or semi-permanent or permanent tissue fillers in the treatment area.
  • Systemic use of a retinoid (such as Accutane) or corticosteroid within 6 months of study participation.
  • Current smoker or history of smoking within 12 months of study participation.
  • Anytime in life, had used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
  • As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01912950


Locations
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United States, New York
Sadick Research Group
New York, New York, United States, 10075
Sponsors and Collaborators
Cutera Inc.

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Responsible Party: Cutera Inc.
ClinicalTrials.gov Identifier: NCT01912950     History of Changes
Other Study ID Numbers: C-13-PW01
First Posted: July 31, 2013    Key Record Dates
Last Update Posted: September 11, 2015
Last Verified: September 2015
Keywords provided by Cutera Inc.:
intense pulsed light
IPL
healthy volunteer
light-based hair removal
hair removal
epilation
laser hair removal
permanent hair reduction
Additional relevant MeSH terms:
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Hypertrichosis
Hair Diseases
Skin Diseases