Clinical Investigation of Safety and Effectiveness of Emerald IPLdevice

NCT03945383 | Completed FDA Device

• 1 other identifier: PC-BEA-Emerald STV&Face-10560
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

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 Emerald IPL-device will be investigated for treatment in face of subjects with ST I - IV and for treatment in face, axilla, bikini area, and legs of subjects with ST V. In-clinic, the study subjects will undergo twelve IPL-treatments bilaterally at the qualified areas (face and / or axilla, bikini line, and legs) with the Emerald IPL device applied by a device operator. Hair re-growth in each area will be evaluated separately and across all skin types. After the 4 bi-weekly treatments, one follow-up visit will be organized two weeks after the 4th treatment. After the completion of the 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

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with at least 30% hair reduction relative to baseline at 8 and 10 weeks after baseline and at 1 and 3 months after last treatment

  Efficacy of the device will be measured by evaluating the proportion of subjects with \>= 30% hair reduction on the face, axilae, bikini area and legs following the intensive treatment phase at 8 and 10 weeks as well as during short term follow up of 1 month and 3 months after the last treatment.

  approximately 13 months

Secondary Outcomes (4)

• Safety will be measured by proportion of treatment-emerged, anticipated adverse events, non-anticipated adverse events, serious adverse events and other related reasons for discontinuation.

  Approximately 22 months

• Assessment of the subjective satisfaction with the treatment results of the Emerald IPL device for removal of unwanted hair on face, axillae, bikini area, and legs: 5-point Likert satisfaction scale

  Approximately 22 months

• Assessment of the acceptance of the Emerald IPL devices for removal of unwanted hair in each body area: Percent of top-two category answers in assessment of acceptance

  Approximately 22 months

• Proportion of subjects with at least 30% hair reduction relative to baseline at 6, 9 and 12 months post-final treatment per body area.

  Approximately 22 months

Other Outcomes (1)

• Exploratory Endpoint

  Approximately 18 months

Study Arms (1)

Treatment with IPL device

EXPERIMENTAL

The Emerald IPL device is applied by the Investigator or designee to the right and left side of the body. Treatment areas are 2x4 cm2 for the leg and bikini line areas. The entire axilla and face (upper lip) area will be treated due to the small area involved.

Device: Treatment with IPL device

Interventions

Treatment with IPL device DEVICE

Treatment with 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
• Are healthy female subjects, in age of 18-65 years
• Have natural body hair color that is dark blonde, brown or black in the designated treatment areas
• Subjects of ST I-IV - Face group:
• Have Fitzpatrick Skin Type I, II, III, or IV
• Measure melanin value ≤ 375 in the qualifying treatment areas bilateral on upper lip (face)
• Have a minimum of 10 hairs in the 1x2cm2 qualifying treatment areas bilateral on upper lip (face), by visual inspection
• Subjects of ST V - All body area group:
• Have Fitzpatrick Skin Type V
• Measure melanin value ≤ 553 in the qualifying treatment areas bilateral on upper lip (face), axilla, bikini line, and leg
• Have a minimum of 10 hairs in the 1x2cm2 qualifying treatment areas bilateral on upper lip (face), by visual inspection
• Have a minimum of 24 hairs in each of the 2x4cm2 qualifying treatment areas bilateral on axilla, bikini line, and leg, by visual inspection
• 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 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

You may not qualify if:

• Have natural body hair color that is white, light blond, or red in the designated treatment areas
• Subjects of ST I to IV - Face group:
• Have Fitzpatrick Skin Type V or VI
• Measure melanin value higher than 375 in the qualifying treatment areas bilateral on upper lip
• Have fewer than 2 qualifying treatment areas on bilateral on upper lip (face)
• Subjects of ST V - All body area group:
• Have Fitzpatrick Skin Type I, II, III, IV, or VI
• Measure melanin value higher than 553 in any of the qualifying treatment areas bilateral on the body
• Have fewer than 8 qualifying treatment areas bilateral: 2 in face, 2 in axilla, 2 on bikini line, and 2 on legs
• Have a malignant or pre-malignant pigment 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 be 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 NSAIDs 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)

Sponsors & Collaborators

• Philips Healthcare: lead

Study Sites (3)

My Community Research Center

Miami, Florida, 33155, United States

Location

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

Virginia Clinical Research

Norfolk, Virginia, 23502, United States

Location

Related Publications (9)

• 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

• Gold MH, Bell MW, Foster TD, Street S. Long-term epilation using the EpiLight broad band, intense pulsed light hair removal system. Dermatol Surg. 1997 Oct;23(10):909-13. doi: 10.1111/j.1524-4725.1997.tb00746.x.

  PMID: 9357500 BACKGROUND

• Gold MH, Bell MW, Foster TD, Street S. One-year follow-up using an intense pulsed light source for long-term hair removal. J Cutan Laser Ther. 1999 Sep;1(3):167-71. doi: 10.1080/14628839950516823.

  PMID: 11360413 BACKGROUND

• Dierickx CC. Hair removal by lasers and intense pulsed light sources. Dermatol Clin. 2002 Jan;20(1):135-46. doi: 10.1016/s0733-8635(03)00052-4.

  PMID: 11859588 BACKGROUND

• Thaysen-Petersen D, Bjerring P, Dierickx C, Nash JF, Town G, Haedersdal M. A systematic review of light-based home-use devices for hair removal and considerations on human safety. J Eur Acad Dermatol Venereol. 2012 May;26(5):545-53. doi: 10.1111/j.1468-3083.2011.04353.x. Epub 2011 Nov 30.

  PMID: 22126235 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

• Rupal Trivedi, M.D.

  Great Lakes Clinical Trials

  PRINCIPAL INVESTIGATOR

• David Pariser, M.D.

  Virginia Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 10, 2019
• Study Start: April 15, 2019
• Primary Completion: January 14, 2022
• Study Completion: January 14, 2022
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)