Removal of Excess or Unwanted Body HairNCT02452398
Clinical Evaluation of Hair Removal and Permanent Hair Reduction for Skin Types VI Using Intense Pulsed Light
A study testing Treatment group in people with Removal of Excess or Unwanted Body Hair, run by Venus Concept at 1 site in United States.
Trial summary
This is a Multi-center, blinded, baseline-controlled, prospective study to evaluate permanent hair reduction and removal for skin types V and VI using IPL. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Removal of Excess or Unwanted Body Hair
- What is being tested?
- Treatment group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 18 Apr 2017
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to read, understand and provide written Informed Consent;
- Subject has black or dark brown terminal hairs in the areas to be treated.
- Terminal hair density requirement of greater than 15 hairs within the hair count site (3x3 cm area) as determined by manual hair count performed by the study investigator.
- Healthy adult, male or female, 21 years of age or older with skin type V-VI;
- Having a suitable treatment area for hair removal;
- Able and willing to comply with the treatment/follow-up schedule and requirements;
- Women of child-bearing potential (women who have not had a hysterectomy, bilateral oophorectomy or are not postmenopausal) are required to be using a reliable method of birth control at least three months prior to enrollment and throughout the course of the study.
Who cannot join
- Subject has light ,gray terminal or fine hairs in all/some parts of the treated area;
- Pregnant, expectation of pregnancy, postpartum or nursing (<6 months);
- Hormonal disorders that may affect hair growth;
- Immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications;
- Livedo reticularis;
- Uncontrolled systemic diseases such as diabetes;
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- Active infections in the treated area;
- Dysplastic nevi;
- Significant concurrent skin conditions or any inflammatory skin conditions;
- Active cold sores, open lacerations or abrasions;
- Chronic or cutaneous viral, fungal, or bacterial diseases;
- Current cancer;
- History of skin cancer or pre-cancerous lesions at the treatment areas;
- Use of Accutane™ (Isotretinoin) within the past six month;
- Keloid or Hypertrophic scar formation in the treatment area;
- Tattoos in the treatment area;
- Bleeding coagulopathies or use of anticoagulants;
- Auto-immune disorders;
- Erythema abigne, when identified treatments should be discontinued;
- Photosensitivity disorder that can be exacerbated by laser or intense light;
- Herpes simplex in the treatment area;
- Use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light;
- Poor wound healing;
- Sunburns;
- Unable or unlikely to refrain from artificial tanning, including the use of tanning booths, prior (at least a month) and during the course of the evaluation;
- Prior skin treatment with laser or other devices on the same treated areas within the last six months prior to study enrollment or during the course of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology and Laser Centre
Manhattan Beach, California, 90266
About this study
Official title: Clinical Evaluation of Hair Removal and Permanent Hair Reduction for Skin Types V-VI Using Intense Pulsed Light
This is a Multi-center, blinded, baseline-controlled, prospective study to evaluate permanent hair reduction and removal for skin types V and VI using IPL.
Read the detailed description
One hundred and twenty (120) subjects who are Fitzpatrick Skin Type V-VI, and have a suitable treatment area for hair removal will be evaluated in this study.
Each subject will receive six treatments at four to six week intervals upon re-growth of hair and return for follow-up visits at one, three and six months after the last treatment.
Measurement Equipment Standard High Resolution Digital Camera
Labels for hair count Customized hair count sticker templates will be placed directly on the skin and the hairs in this window will be counted at specific visits during the study as detailed in section.
Study Procedures Each subject will participate in the study for a period of at least 11 months. The study is anticipated to be completed within twelve months.
Test spots Up to 3 test spots will be performed in the selected treatment area to determine the optimal parameters / setting.
Treatment
The treatment areas are divided into 3 groups. Each Subjects will be allocated to one of the following groups::
- Two small anatomical areas (right and left axillae and double sided bikini line) or;
- One double sided large area (right and left thighs) or;
- One large area (whole back / abdomen)
Based on the mild nature of treatment, anesthesia is not required. Before starting treatment apply a layer of conductive gel to the treatment area.
After applying the conductive gel, locate the applicator in close contact, perpendicular to the skin with no pressure applied. Pressing the applicator will fire the IPL pulse. In order to ensure full coverage of the treatment area applicator placement should overlap approximately 1/3 of the previously treated skin.
Post-treatment Instructions Cold packs may be placed on the treated area for post treatment cooling. Subjects should be aware that post treatment erythema, edema and some discomfort of the treated areas are possible and should not be a cause for concern. They may also experience some purpura in the treated areas which would be expected to resolve within several days.
- Conditions
- Removal of Excess or Unwanted Body Hair
- Being tested
- Treatment group, No intervention
- Keywords
- Hair removal, depilation, epilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment groupDevice
The intense pulsed light (IPL) applicator with a wavelength of 690 nm and spot size (treatment area) of 30 mm by 10 mm will be used to deliver the energy to the treatment area.
No interventionOther
Subject will act as their own control where the baseline hair count will be used as a comparator to the hair count after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Hair removal treatment using Venus Versa IPL energy Receives: Device: Treatment group; Other: No intervention |
| No intervention | Placebo comparator | Subject hair count at baseline will act as the control to which the hair count at 6 months after the last treatment. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair Count 6 Months Following Last Treatment
Hair count reduction in marked treatment area assessed from photographs taken 6 months following the last treatment as compared to photographs of the marked treatment area taken at baseline.
Measured: 6 months after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startJan 2015
- Primary completion27 Mar 2017
- Study completion18 Apr 2017
Why it stopped: Study withdrawn as technology already proven with data no longer needed.
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 Removal of Excess or Unwanted Body HairStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venus Concept
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tracey L Mancuso, Study director, Venus Concept
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452398
- Sponsor's protocol ID
- CS0115
- Status last verified
- Oct 2020
- First submitted
- 8 May 2015
- Last updated
- 3 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Hair Removal and Permanent Hair Reduction for Skin Types V-VI Using Intense Pulsed Light
- ClinicalTrials.gov ID
- NCT02452398
- Acronym / sponsor ID
- CS0115
- Conditions
- Removal of Excess or Unwanted Body Hair
- Keywords
- Hair removal, depilation, epilation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study withdrawn as technology already proven with data no longer needed.
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Venus ConceptIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- 27 Mar 2017 (actual)
- Study completion
- 18 Apr 2017 (actual)
- First posted
- 22 May 2015 (estimated)
- Results
- Posted 3 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Multi-center, blinded, baseline-controlled, prospective study to evaluate permanent hair reduction and removal for skin types V and VI using IPL.
Detailed description
One hundred and twenty (120) subjects who are Fitzpatrick Skin Type V-VI, and have a suitable treatment area for hair removal will be evaluated in this study.
Each subject will receive six treatments at four to six week intervals upon re-growth of hair and return for follow-up visits at one, three and six months after the last treatment.
Measurement Equipment Standard High Resolution Digital Camera
Labels for hair count Customized hair count sticker templates will be placed directly on the skin and the hairs in this window will be counted at specific visits during the study as detailed in section.
Study Procedures Each subject will participate in the study for a period of at least 11 months. The study is anticipated to be completed within twelve months.
Test spots Up to 3 test spots will be performed in the selected treatment area to determine the optimal parameters / setting.
Treatment
The treatment areas are divided into 3 groups. Each Subjects will be allocated to one of the following groups::
- Two small anatomical areas (right and left axillae and double sided bikini line) or;
- One double sided large area (right and left thighs) or;
- One large area (whole back / abdomen)
Based on the mild nature of treatment, anesthesia is not required. Before starting treatment apply a layer of conductive gel to the treatment area.
After applying the conductive gel, locate the applicator in close contact, perpendicular to the skin with no pressure applied. Pressing the applicator will fire the IPL pulse. In order to ensure full coverage of the treatment area applicator placement should overlap approximately 1/3 of the previously treated skin.
Post-treatment Instructions Cold packs may be placed on the treated area for post treatment cooling. Subjects should be aware that post treatment erythema, edema and some discomfort of the treated areas are possible and should not be a cause for concern. They may also experience some purpura in the treated areas which would be expected to resolve within several days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Treatment group, Other: No interventionHair removal treatment using Venus Versa IPL energy |
| No intervention | Placebo comparator | Other: No interventionSubject hair count at baseline will act as the control to which the hair count at 6 months after the last treatment. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to read, understand and provide written Informed Consent;
- Subject has black or dark brown terminal hairs in the areas to be treated.
- Terminal hair density requirement of greater than 15 hairs within the hair count site (3x3 cm area) as determined by manual hair count performed by the study investigator.
- Healthy adult, male or female, 21 years of age or older with skin type V-VI;
- Having a suitable treatment area for hair removal;
Key exclusion criteria (26 listed)
- Subject has light ,gray terminal or fine hairs in all/some parts of the treated area;
- Pregnant, expectation of pregnancy, postpartum or nursing (<6 months);
- Hormonal disorders that may affect hair growth;
- Immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications;
- Livedo reticularis;
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 |
|---|---|---|
| Treatment groupThe intense pulsed light (IPL) applicator with a wavelength of 690 nm and spot size (treatment area) of 30 mm by 10 mm will be used to deliver the energy to the treatment area. | Device | Treatment Group |
| No interventionSubject will act as their own control where the baseline hair count will be used as a comparator to the hair count after treatment. | Other | No intervention, Treatment Group |
Primary outcome
Hair Count 6 Months Following Last Treatment
Time frame: 6 months after last treatment
Hair count reduction in marked treatment area assessed from photographs taken 6 months following the last treatment as compared to photographs of the marked treatment area taken at baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Tracey L Mancuso study director
Venus Concept
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment group in people with Removal of Excess or Unwanted Body Hair, run by Venus Concept 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 7 inclusion and 26 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: stopped early, as of the sponsor's last update on 3 Nov 2020. 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. Some participants in this study may receive a placebo. 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 3 Nov 2020). 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?
Hair Count 6 Months Following Last Treatment (time frame: 6 months after last treatment). 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 3 Nov 2020.