Dyschromia, Photosensitivity Disorders, Pigmentation Disorders, Poikiloderma of Civatte, Telangiectasia
Conditions
Keywords
poikiloderma of Civatte, red dyschromia, brown dyschromia, sun damage, neck, chest, dyschromia, pigmentation disorders, erythema, photosensitivity disorders, sun exposure, telangiectasia, hyperpigmentation, hypopigmentation
Brief summary
This study will evaluate the safety and efficacy of the Excel V 532 nm KTP laser for the treatment of dyschromia of the neck and/or chest (poikiloderma of Civatte).
Interventions
DEVICE532 nm KTP laser
Laser treatment sessions on the neck and/or chest
Sponsors
Cutera Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Fitzpatrick Skin Type I - III * Clinical diagnosis of poikiloderma of Civatte affecting the neck and/or chest * Willing to refrain from using topical corticosteroids, retinoids and bleaching agents on the treated area * Agree not to undergo any other procedure for the treatment of poikiloderma of Civatte during the study * Willing and able to read, understand and sign the Informed Consent Form * Willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions
Exclusion criteria
* Any laser treatment on neck and/or chest within 12 months * Any topical treatment on neck and/or chest within 6 months * Pregnant and/or breastfeeding * Infection, dermatitis or a rash in the treatment area * Suffering from significant concurrent illness, such as Diabetes Mellitus or pertinent neurological disorders * History of seizure disorders due to light, fibromyalgia, connective tissue disease, vitiligo, psoriasis, pigmentary disorders, keloid scarring, hypertrophic scarring or abnormal wound healing * History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications * Having a known anticoagulative condition or taking anticoagulation medications * History of diseases stimulated by heat, unless treatment is conducted following a prophylactic regimen * Having undergone any surgery in the treatment area within 6 months of treatment (or more if skin has not healed completely) * History of radiation to the head, neck and/or upper chest * Undergoing systemic chemotherapy for the treatment of cancer * Systemic use of isotretinoin (Accutane®) within 6 months * Any use of gold therapy * Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study * Current smoker or history of smoking within 12 months of study * Participation in a study of another device or drug within 6 months * As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity Assessment Score | 24 weeks | Change in Physician's Severity Assessment score based on blinded assessment of subject photographs by a panel of independent dermatologists. Blinded Physician's Severity Assessment (min=1;max=4); Higher scores mean worse values |
| Physician's Global Assessment (Blinded) | 24 weeks | Before and after subject photographs were presented to a panel of independent dermatologists. The panel was blinded to treatment parameters and the photograph time points. Each dermatologist was asked to select the baseline photograph and then rate improvement in Poikiloderma of Civatte in the post-treatment photograph using a 5-point improvement scale. Physician's Global Assessment (min= -1; max=4) Higher scores mean better outcome |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 532 nm KTP Laser Treatment 532 nm KTP laser: Two laser treatment sessions to neck and/or chest. 6 weeks apart. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | 532 nm KTP Laser Treatment |
|---|---|
| Age, Continuous | 52.5 years |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 24 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Physician's Global Assessment (Blinded)
Before and after subject photographs were presented to a panel of independent dermatologists. The panel was blinded to treatment parameters and the photograph time points. Each dermatologist was asked to select the baseline photograph and then rate improvement in Poikiloderma of Civatte in the post-treatment photograph using a 5-point improvement scale. Physician's Global Assessment (min= -1; max=4) Higher scores mean better outcome
Time frame: 24 weeks
Population: Only 5 subjects were treated and then assessed at 24 weeks in their upper chest area
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 532 nm KTP Laser Treatment | Physician's Global Assessment (Blinded) | Upper Chest Area | 1 score on a scale | Standard Deviation 0.71 |
| 532 nm KTP Laser Treatment | Physician's Global Assessment (Blinded) | Neck Area | .06 score on a scale | Standard Deviation 0.97 |
Primary
Severity Assessment Score
Change in Physician's Severity Assessment score based on blinded assessment of subject photographs by a panel of independent dermatologists. Blinded Physician's Severity Assessment (min=1;max=4); Higher scores mean worse values
Time frame: 24 weeks
Population: Only 5 subjects were treated and then assessed at 24 weeks in their upper chest area
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 532 nm KTP Laser Treatment | Severity Assessment Score | Upper Chest | 0.2 score on a scale | Standard Deviation 0.45 |
| 532 nm KTP Laser Treatment | Severity Assessment Score | Neck | -0.06 score on a scale | Standard Deviation 0.66 |