HypertrichosisNCT01912950
Pilot Study of a Novel IPL for Removal of Unwanted Fine Body Hair
A study testing Prowave LX IPL in people with Hypertrichosis, run by Cutera Inc. at 1 site in United States.
Trial 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 IPL treatment on one forearm area. Another area will serve as the un-treated control area. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertrichosis
- What is being tested?
- Prowave LX IPL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hypertrichosis
- Being tested
- Prowave LX IPL
- Keywords
- intense pulsed light, IPL, healthy volunteer, light-based hair removal, hair removal, epilation, laser hair removal, permanent hair reduction
- Medical subject headings
- Hypertrichosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prowave LX IPLDevice
Also called Prowave, Prowave LX, Cutera Prowave LX, Intense Pulsed Light
| Study group | Role | What they receive |
|---|---|---|
| Prowave LX IPL | Experimental | One area on forearm will receive treatment with Prowave LX IPL Receives: Device: Prowave LX IPL |
| No Treatment | No intervention | No treatment administered on one area of forearm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Percent Hair Reduction Between Treatment Arm and Non-treated Control Arm at 12 Weeks Post Final Treatment
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startDec 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertrichosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neil Sadick, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912950
- Sponsor's protocol ID
- C-13-PW01
- Status last verified
- Jan 2023
- First submitted
- 18 Jul 2013
- Last updated
- 21 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Open-Label Pilot Study of a Novel IPL for Removal of Unwanted Fine Hair
- ClinicalTrials.gov ID
- NCT01912950
- Acronym / sponsor ID
- C-13-PW01
- Conditions
- Hypertrichosis
- Keywords
- intense pulsed light, IPL, healthy volunteer, light-based hair removal, hair removal, epilation, laser hair removal, permanent hair reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 31 Jul 2013 (estimated)
- Results
- Posted 21 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prowave LX IPL | Experimental | Device: Prowave LX IPLOne area on forearm will receive treatment with Prowave LX IPL |
| No Treatment | No intervention | –No treatment administered on one area of forearm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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".
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prowave LX IPLAlso: Prowave, Prowave LX, Cutera Prowave LX, Intense Pulsed Light | Device | Prowave LX IPL |
Primary outcome
Comparison of Percent Hair Reduction Between Treatment Arm and Non-treated Control Arm at 12 Weeks Post Final Treatment
Time frame: 12-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hypertrichosis
RecruitingObservational study
Treatment of Hypertrichosis With Intense Pulsed Light
Hypertrichosis, Hirsutism - Hypertrichosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Sadick principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prowave LX IPL in people with Hypertrichosis, run by Cutera Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Percent Hair Reduction Between Treatment Arm and Non-treated Control Arm at 12 Weeks Post Final Treatment (time frame: 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.