Sunstone IPL (Intense Pulsed Light) for Hair Reduction
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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).
Enrollment
Sex
Ages
Volunteers
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
- 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)
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)
-
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
-
Have a history of keloid scar formation
-
Have a history of herpes outbreaks in the designated treatment areas
-
Have a history of photosensitive epilepsy
-
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
-
Have diabetes, or metabolic disease that affects hair growth
-
Taking immunosuppressive medication(s)
-
Have a disease related to photosensitivity, such as polymorphic light eruption (PMLE), solar urticaria, porphyria etc.
-
Have a history of skin cancer, including past basal cell carcinoma and/or squamous cell carcinoma in the designated treatment areas
-
Have a history of any radiation therapy in any of the designated treatment areas
-
Have a history of radiation therapy in non-treatment areas within 5 years
-
Have a history of chemotherapy
-
Have used hair growth inhibitors and/or accelerators within 6 months preceding enrolment
-
Have had laser or electrolysis treatment for the removal of hair in the treatment sites within the last year
-
Have natural body hair colors of white, grey, light to mid-blond, or red in the designated treatment areas
-
Have bleaching of the body hair in the designated treatment areas 6 months prior to study enrolment
-
Have shaved treatment areas within 7 days prior to study enrolment
-
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
102 participants in 1 patient group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal