AzTrials
AzTrials

Hair RemovalNCT03921814

Sunstone IPL (Intense Pulsed Light) for Hair Reduction

A study testing Treatment with IPL device in people with Hair Removal, run by Philips Healthcare at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a prospective, multi-center, single-arm, single blinded study to evaluate the safety and efficacy of the Sunstone IPL (Intense Pulsed Light) device to remove hair. Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Hair Removal
What is being tested?
Treatment with IPL device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
2 sitesUnited States
Study dates
11 Apr 2019to 20 May 2022
Phase
Interventional
Are there results?
None posted in the registry

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
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Be willing to provide informed consent
  • Have a minimum of 24 hairs in each of the 2x4cm2 treatment area in axilla, bikini line, and leg, by visual inspection
  • Have a minimum of 10 hairs in the 1x2cm2 treatment area in face (upper lip), by visual inspection
  • Have a Fitzpatrick Skin Type I to V, with a melanin index less or equal to 553, as measured by Mexameter MX 18 in the designated treatment areas on face, axilla, bikini, and legs
  • Have natural body hair color that is dark blonde to black in the designated treatment areas
  • Are female subjects 18-65 years of age
Show all 12Show fewer
  • Be either post-menopausal or surgically sterilized, or using a medically acceptable form of birth control (e.g., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence, etc.).
  • Be willing to participate in all scheduled study visits
  • Be willing to refrain from deliberate exposure to strong sun, products or procedures that would cause the skin to become darker in the designated treatment areas during the treatment phase
  • Be willing to refrain from the use of hair growth inhibitors/accelerators during the course of the study
  • Be willing to refrain from waxing, depilating or epilating of the face (upper lip), axilla, bikini line, and leg during the course of the study
  • Be willing to refrain from using aspirin or NSAIDS (e.g. acetaminophen, ibuprofen, etc.) within 5 days prior to and 5 days after treatment(s)

Who cannot join

  • Have fewer than 8 qualifying treatment areas: 2 in face (upper lip), 2 in axilla, 2 on bikini line, 2 on leg)
  • Have a malignant or pre-malignant pigmented lesion in the area to be treated
  • Have scarring or infection of the area to be treated
  • Have a known history of photosensitivity or use of medication known to induce photosensitivity
  • Are currently pregnant or lactating or planning to become pregnant in the period of the study, per subject report
  • Are currently on a daily dose of aspirin or NSAIDS (e.g. acetaminophen, ibuprofen, etc.) or have taken aspirin and/or NSAID within 5 days prior to treatment that would reduce or increase the sensation of pain
Show all 33Show fewer
  • Are not willing to abstain from the use of products or light exposure that would induce tanning in the treatment areas during the IPL treatment period (first 10 months)
  • Have a history of immunosuppressive disease (including HIV infection or AIDS)
  • Are on anticoagulative medication or have thromboembolic condition
  • Any form of isotretinoin (such as Accutane or Roaccutane etc.) in the last six months.
  • Have an active implantable device such as a pacemaker, neurostimulator or internal defibrillator
  • Have used waxing or other methods of root hair removal, or photo-epilation within 6 months prior to treatment
  • Have been exposed to strong sunlight or an artificial tanning machine within 4 weeks of enrolment
  • Have a tattoo(s), warts, moles, benign skin lesions, dark pigmented areas, permanent make-up etc. in the treatment areas.
  • Have eczema, psoriasis, lesions, open wounds or any skin affliction in the treatment areas
  • Have a history of keloid scar formation
  • Have a history of herpes outbreaks in the designated treatment areas
  • Have a history of photosensitive epilepsy
  • Have a condition related to hormonal changes like polycystic ovarian syndrome (PCOS) or taking drugs leading to hormonal changes resulting in excessive hair growth like hirsutism and idiopathic hirsutism
  • Have diabetes, or metabolic disease that affects hair growth
  • Taking immunosuppressive medication(s)
  • Have a disease related to photosensitivity, such as polymorphic light eruption (PMLE), solar urticaria, porphyria etc.
  • Have a history of skin cancer, including past basal cell carcinoma and/or squamous cell carcinoma in the designated treatment areas
  • Have a history of any radiation therapy in any of the designated treatment areas
  • Have a history of radiation therapy in non-treatment areas within 5 years
  • Have a history of chemotherapy
  • Have used hair growth inhibitors and/or accelerators within 6 months preceding enrolment
  • Have had laser or electrolysis treatment for the removal of hair in the treatment sites within the last year
  • Have natural body hair colors of white, grey, light to mid-blond, or red in the designated treatment areas
  • Have bleaching of the body hair in the designated treatment areas 6 months prior to study enrolment
  • Have shaved treatment areas within 7 days prior to study enrolment
  • Participating in other clinical studies prior to, or concurrently with this study, that could be deemed to interfere with full and complete participation in this study - as determined by the site Investigator.
  • -

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Sera Collection

    Montebello, California, 90640

  • Sadick Research Group

    New York, New York, 10075

Other trials in United States

About this study

Official title: Clinical Investigation of Safety and Efficacy of a Philips Intense Pulsed Light Device for Hair Reduction (Sunstone 2019)

This is a prospective, multi-center, single-arm, single blinded study to evaluate the safety and efficacy of the Sunstone IPL (Intense Pulsed Light) device to remove hair.

Read the detailed description

Prospective, multi-center, single-arm, single blinded (Philips hair counter) study in healthy women of skin types I up to and including V.

Safety and efficacy of hair removal with the Investigational Philips IPL-device will be investigated.

In-clinic, each study subject will undergo twelve IPL-treatments at four areas bilaterally (face, axilla, bikini line, and legs) with an investigational IPL device applied by a device operator.

Hair re-growth in four body areas, face, axillae, bikini line and leg will be evaluated separately.

After the 4 bi-weekly treatments, one follow-up visit will be organized. After the completion of full treatment cycle (12 treatments), subjects will be followed for 1 and 3 months (short-term follow-up) and for 6, 9 and 12 months (long-term follow up).

Conditions
Hair Removal
Being tested
Treatment with IPL device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment with IPL deviceDevice

    Exposure of body parts to the IPL device

Study groups in NCT03921814
Study groupRoleWhat they receive
Treatment with IPL deviceExperimentalThis study will be conducted in women, aged 18 to 65 years, with skin types I up to and including V, and measured melanin values of ≤ 553 Melanin index in each qualifying treatment area in face (upper lip), axilla, bikini line, and leg. Each of the 2cm x 4cm treatment area bilateral located in axilla, bikini line and leg should count a minimum of 24 hairs. In face (upper lip) on upper lip, a minimum of 10 hairs should be available in each of the 1cm x 2cm selected treatment area bilateral located. The procedure to define the treatment area is described in the Training Manual [5]. Skin type must be determined based on an evaluation by a dermatologist or designee at site according to the Fitzpatrick Skin Type Scale.
Receives: Device: Treatment with IPL device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of safety of the Sunstone IPL device on removal of unwanted hair on face, axillae, bikini area and legs over the course of the treatment (12 treatments) and follow up (12 months).

    The analysis of the Primary safety endpoint will be based on the safety population which include all the enrolled subjects with at least one treatment. The primary safety endpoints include the treatment-emerged, anticipated adverse events (e.g. pain/discomfort, anticipated skin reactions.), non-anticipated adverse events, serious adverse events and reasons for discontinuation. Pain/discomfort will be evaluated per treatment per body area using the 5-point pain score grade. The percentage of the top-two scores will be calculated. Skin reactions will be assessed per treatment and body area, and will be described for type, onset, duration and severity. Incidence of adverse events will be summarized by frequency, severity and by relationship to device. Safety data will be summarized with descriptive statistics by body area, time points and clinical sites and combined.

    Measured: approximately 18 months

  2. Evaluation of the efficacy of the Sunstone IPL device on short-term hair reduction on face, axillae, bikini area and legs, 1 month after the last treatment (12 treatments).

    The primary efficacy endpoint is the proportion of subjects with successful hair reduction at 1 month post-final treatment per body area. Successful hair reduction is defined as an average reduction in hair count at the given time point, that is greater than or equal to 30% relative to baseline hair count. Post-final treatment is defined as time point after the last of 12 treatments.

    Measured: approximately 11 months

  3. Evaluation of the efficacy of the Sunstone IPL device on short-term hair reduction on face, axillae, bikini area and legs, 3 months after the last treatment (12 treatments).

    The primary efficacy endpoint is the proportion of subjects with successful hair reduction at 3 months post-final treatment per body area. Successful hair reduction is defined as an average reduction in hair count at the given time point, that is greater than or equal to 30% relative to baseline hair count. Post-final treatment is defined as time point after the last of 12 treatments.

    Measured: approximately 14 months

Secondary outcomes (6)

  1. 4. Evaluation of the efficacy of the Sunstone IPL device on removal of unwanted hair on face, axillae, bikini area, and legs after the initial, intensive treatment phase at 8 weeks after baseline (2 weeks after the 4th treatment).

    Proportion of subjects with successful hair reduction (greater than or equal to 30% relative to baseline) at 8 weeks post-baseline (2 weeks after the 4th treatment) per body area.

    Measured: Approximately 2 months

  2. 5. Evaluation of the efficacy of the Sunstone IPL device on removal of unwanted hair on face, axillae, bikini area, and legs after the initial, intensive treatment phase at 10 weeks after baseline (4 weeks after the 4th treatment).

    Proportion of subjects with successful hair reduction (greater than or equal to 30% relative to baseline) at 10 weeks post-baseline (4 weeks after the 4th treatment) per body area.

    Measured: Approximately 4.5 months

  3. 6. Evaluation of the stable long-term hair reduction efficacy in face, axillae, bikini area and legs, 6, 9 and 12 months after completion of the 12 treatments with the Sunstone IPL device.

    Proportion of subjects with successful hair reduction (greater than or equal to 30% relative to baseline) at 6, 9 and 12 months post-final treatment (12 treatments) per body area.

    Measured: Approximately 22 months

  4. 7. Assessment of the subjective satisfaction with the treatment results of the Sunstone IPL device s for removal of unwanted hair on face, axillae, bikini area, and legs.

    Percent of top-two category answers of 5-point Likert satisfaction scale in assessment of subjective satisfaction with the treatment results in all body areas.

    Measured: Approximately 22 months

  5. 8. Assessment of the acceptance of the Philips investigational IPL devices for removal of unwanted hair in each body area.

    Percent of top-two category answers in assessment of acceptance of hair reduction, skin smoothness, and comfort after treatment with Philips investigational IPL devices in all body areas.

    Measured: Approximately 22 months

  6. Evaluate time course of hair reduction during first four treatments

    Evaluate the time course of hair reduction to baseline achieved by the Philips investigational IPL device for each body area during the first four treatments, i.e. during the Intensive Treatment phase.

    Measured: Approximately 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2019
  2. Study start11 Apr 2019
  3. Primary completion23 Sep 2021
  4. Study completion20 May 2022

Resources

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
Not applicable
Intervention model
Single group
Model description
All enrolled subjects will be treated with the investigation device.
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03921814
Sponsor's protocol ID
PC-BEA-Sunstone-2018-10510
Status last verified
Oct 2022
First submitted
1 Apr 2019
Last updated
20 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Altshuler GB, Anderson RR, Manstein D, Zenzie HH, Smirnov MZ. Extended theory of selective photothermolysis. Lasers Surg Med. 2001;29(5):416-32. doi: 10.1002/lsm.1136.

    PubMed 11891730

  • Ravnbak MH. Objective determination of Fitzpatrick skin type. Dan Med Bull. 2010 Aug;57(8):B4153.

    PubMed 20682135

  • Shamsuddin K et. al, The reliability of Fitzpatrick Skin Type Chart Comparing to Mexameter (Mx 18) in measuring skin color among first trimester, Malaysian Journal of Public Health Medicine 2016, Vol. 16 (3): 59-65

  • Town G, Ash C, Dierickx C, Fritz K, Bjerring P, Haedersdal M. Guidelines on the safety of light-based home-use hair removal devices from the European Society for Laser Dermatology. J Eur Acad Dermatol Venereol. 2012 Jul;26(7):799-811. doi: 10.1111/j.1468-3083.2011.04406.x. Epub 2012 Jan 3.

    PubMed 22211702

  • Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.

    PubMed 3377516

Questions about this trial

What is this clinical trial studying?

A study testing Treatment with IPL device in people with Hair Removal, run by Philips Healthcare at 2 sites 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 33 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 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Evaluation of safety of the Sunstone IPL device on removal of unwanted hair on face, axillae, bikini area and legs over the course of the treatment (12 treatments) and follow up (12 months). (time frame: approximately 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03921814, which also lists 5 linked publications.

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 20 Oct 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in