Sunstone IPL (Intense Pulsed Light) for Hair Reduction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-11

Study Completion Date

2022-05-20

Brief Summary

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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.

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Detailed Description

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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

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Hair Removal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All enrolled subjects will be treated with the investigation device.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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

Study Groups

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Treatment with IPL device

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.

Group Type EXPERIMENTAL

Treatment with IPL device

Intervention Type DEVICE

Exposure of body parts to the IPL device

Interventions

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Treatment with IPL device

Exposure of body parts to the IPL device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Be willing to provide informed consent
2. Have a minimum of 24 hairs in each of the 2x4cm2 treatment area in axilla, bikini line, and leg, by visual inspection
3. Have a minimum of 10 hairs in the 1x2cm2 treatment area in face (upper lip), by visual inspection
4. 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
5. Have natural body hair color that is dark blonde to black in the designated treatment areas
6. Are female subjects 18-65 years of age
7. 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.).
8. Be willing to participate in all scheduled study visits
9. 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
10. Be willing to refrain from the use of hair growth inhibitors/accelerators during the course of the study
11. 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
12. 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)

Exclusion Criteria

1. Have fewer than 8 qualifying treatment areas: 2 in face (upper lip), 2 in axilla, 2 on bikini line, 2 on leg)
2. Have a malignant or pre-malignant pigmented lesion in the area to be treated
3. Have scarring or infection of the area to be treated
4. Have a known history of photosensitivity or use of medication known to induce photosensitivity
5. Are currently pregnant or lactating or planning to become pregnant in the period of the study, per subject report
6. 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
7. 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)
8. Have a history of immunosuppressive disease (including HIV infection or AIDS)
9. Are on anticoagulative medication or have thromboembolic condition
10. Any form of isotretinoin (such as Accutane or Roaccutane etc.) in the last six months.
11. Have an active implantable device such as a pacemaker, neurostimulator or internal defibrillator
12. Have used waxing or other methods of root hair removal, or photo-epilation within 6 months prior to treatment
13. Have been exposed to strong sunlight or an artificial tanning machine within 4 weeks of enrolment
14. Have a tattoo(s), warts, moles, benign skin lesions, dark pigmented areas, permanent make-up etc. in the treatment areas.
15. Have eczema, psoriasis, lesions, open wounds or any skin affliction in the treatment areas
16. Have a history of keloid scar formation
17. Have a history of herpes outbreaks in the designated treatment areas
18. Have a history of photosensitive epilepsy
19. 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
20. Have diabetes, or metabolic disease that affects hair growth
21. Taking immunosuppressive medication(s)
22. Have a disease related to photosensitivity, such as polymorphic light eruption (PMLE), solar urticaria, porphyria etc.
23. Have a history of skin cancer, including past basal cell carcinoma and/or squamous cell carcinoma in the designated treatment areas
24. Have a history of any radiation therapy in any of the designated treatment areas
25. Have a history of radiation therapy in non-treatment areas within 5 years
26. Have a history of chemotherapy
27. Have used hair growth inhibitors and/or accelerators within 6 months preceding enrolment
28. Have had laser or electrolysis treatment for the removal of hair in the treatment sites within the last year
29. Have natural body hair colors of white, grey, light to mid-blond, or red in the designated treatment areas
30. Have bleaching of the body hair in the designated treatment areas 6 months prior to study enrolment
31. Have shaved treatment areas within 7 days prior to study enrolment
32. 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.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes