CompletedNot Applicable

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 range18 Years – 65 Years

SexFEMALE

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)
✕. 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)

What they're measuring

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

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

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).

Timeframe: approximately 14 months

Trial details

NCT IDNCT03921814

SponsorPhilips Healthcare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-09-23

View on ClinicalTrials.gov More Hair Removal trials