- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01912950
Pilot Study of a Novel IPL for Removal of Unwanted Fine Body Hair
January 26, 2023 updated by: Cutera Inc.
Randomized, Controlled, Open-Label Pilot Study of a Novel IPL for Removal of Unwanted Fine Hair
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 IPL treatment on one forearm area. Another area will serve as the un-treated control area. Subjects will be followed at 12-weeks post-final treatment.
Study Overview
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10075
- Sadick Research Group
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prowave LX IPL
One area on forearm will receive treatment with Prowave LX IPL
|
Other Names:
|
No Intervention: No Treatment
No treatment administered on one area of forearm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of Percent Hair Reduction Between Treatment Arm and Non-treated Control Arm at 12 Weeks Post Final Treatment
Time Frame: 12-weeks
|
12-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Neil Sadick, Study Principal Investigator
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
July 18, 2013
First Submitted That Met QC Criteria
July 29, 2013
First Posted (Estimate)
July 31, 2013
Study Record Updates
Last Update Posted (Estimate)
February 21, 2023
Last Update Submitted That Met QC Criteria
January 26, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-13-PW01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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