Pigmented Skin Lesion of Suspected Benign Nature Clinical Trial
Official title:
A Clinical Evaluation of a Novel Multi-Wavelength Laser for Benign Pigmented Lesion Removal
| NCT number | NCT02635880 |
| Other study ID # | C-15-EN08 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 2015 |
| Est. completion date | March 23, 2016 |
| Verified date | January 2016 |
| Source | Cutera Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To evaluate the safety and efficacy of an investigational version of the Cutera enlightenTM laser that offers multiple wavelengths for removal of benign pigmented lesions.
| Status | Completed |
| Enrollment | 32 |
| Est. completion date | March 23, 2016 |
| Est. primary completion date | February 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Female or Male, 18 to 65 years of age (inclusive). - Fitzpatrick Skin Type I - III (Appendix 3). - Clinical diagnosis of benign pigmented lesions located on the hand, body or face. - Presence of 5 or more benign pigmented lesions in the treatment area, ranging in diameter from 2 to 8 mm. - Has not used any prescription or over-the-counter topical creams (such as hydroquinone, retinoids or corticosteroids) in the designated treatment area within 4 weeks of enrollment in the study and is willing to refrain from use for the duration of the study. - Subject must be able to read, understand and sign the Informed Consent Form. - Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions. - Wiling to cover treated area or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated area starting 2 to 4 weeks before the treatment and every day for the duration of the study, including the follow-up period. - Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes. - Agree to not undergo any other procedure(s) for the treatment of BPL during the study. - Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant for the duration of the study. Exclusion Criteria: - Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study. - Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as chemical peel, laser or light-based procedure, or surgery. - Presence of pre-malignant or malignant lesion in the treatment area (such as, but not limited to pigmented actinic keratosis, lentigo maligna or lentigo maligna melanoma) or history of a pre-malignant or malignant lesion in the treatment area. - Shows signs of actinic bronzing and/or excessively tanned in areas to be treated, and unable or unlikely to refrain from tanning during the study (for example, subject's occupation requires regular sun exposure). - Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles. - Pregnant and/or breastfeeding. - Having an infection, dermatitis or a rash in the treatment area. - Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension. - Suffering from coagulation disorders or taking prescription anticoagulation medications. - History of keloid scarring, hypertrophic scarring or of abnormal wound healing. - History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications. - History of vitiligo, eczema, or psoriasis. - History of connective tissue disease, such as systemic lupus erythematosus or scleroderma. - History of seizure disorders due to light. - Any use of medication that is known to increase sensitivity to light according to Investigator's discretion. - History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen - History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer. - History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation. - Systemic use of corticosteroid or isotretinoin within 12 months of study participation. - Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus. - Current smoker or history of smoking within 6 months of study participation. - As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Cutera Research Center | Brisbane | California |
| Lead Sponsor | Collaborator |
|---|---|
| Cutera Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Change of Treated Lesions | Degree of change in treated lesions at 6 weeks post-final treatment as assessed using the Global Aesthetic Improvement Scale (GAIS) with a scoring of 0 - for no change, 1 - Mild Improvement, 2 - Moderate Improvement, 3 - Significant Improvement, 4 - Very SIgnificant Improvement. | Baseline and 6 weeks post-final treatment | |
| Secondary | Percentage of Particpant Satisfaction of Improvement in Treated Lesions by the Subject | Degree of improvement in treated lesions at 6 weeks post-final treatment as assessed by the subject through a customized subject satisfaction survey. Survey was based upon a scoring 0 - Extremely Unsatisfied, 1 - Unsatisfied, 2 - Neutral, 3- Satisfied, 4 - Extremely Satisfied. | 6 weeks post-final treatment |