Sunstone IPL (Intense Pulsed Light) for Hair Reduction
United States102 participantsStarted 2019-04-11
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Have fewer than 8 qualifying treatment areas: 2 in face (upper lip), 2 in axilla, 2 on bikini line, 2 on leg)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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).
Timeframe: 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).
Timeframe: 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).
. 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)