Sunstone IPL (Intense Pulsed Light) for Hair Reduction

NCT03921814 | Completed FDA Device

• 1 other identifier: PC-BEA-Sunstone-2018-10510
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hair Removal

Outcome Measures

Primary Outcomes (3)

• 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.

  approximately 18 months

• 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.

  approximately 11 months

• 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.

  approximately 14 months

Secondary Outcomes (6)

• 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).

  Approximately 2 months

• 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).

  Approximately 4.5 months

• 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.

  Approximately 22 months

• 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.

  Approximately 22 months

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

  Approximately 22 months

Other Outcomes (1)

• Exploratory objective to assess subjective selection of setting compared to device setting

  Approximately 18 months

Study Arms (1)

Treatment with IPL device

EXPERIMENTAL

This 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.

Device: Treatment with IPL device

Interventions

Treatment with IPL device DEVICE

Exposure of body parts to the IPL device

Treatment with IPL device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Philips Healthcare: lead

Study Sites (2)

Sera Collection

Montebello, California, 90640, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

Related Publications (5)

• 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.

  PMID: 11891730 BACKGROUND

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

  PMID: 20682135 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 22211702 BACKGROUND

• 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.

  PMID: 3377516 BACKGROUND

MeSH Terms

Interventions

Therapeutics

Study Officials

• Gary Lotz

  Head of Global Clinical and Scientific Affairs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Periodic photographs are taken of the treatment areas. The photos are labeled with a randomized bar code label. Hair counters will review the photos and count the hairs
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All enrolled subjects will be treated with the investigation device.

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 19, 2019
• Study Start: April 11, 2019
• Primary Completion: September 23, 2021
• Study Completion: May 20, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)