Wrinkles
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of the treatment of wrinkles using a 755nm Alexandrite Laser.
Interventions
DEVICE755nm Alexandrite Laser
755nm Alexandrite Laser for the treatment of Wrinkles
Sponsors
Cynosure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Is a healthy non-smoking (must have quit 6 months prior) male or female between 18 and 65 years old. 2. Is willing to consent to participate in the study. 3. Is willing to comply with all requirements of the study including biopsies, being photographed, following post treatment care and attending all treatment and follow up visits.
Exclusion criteria
1. The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period. 2. The subject is hypersensitive to light exposure OR takes photo sensitized medication. 3. The subject has active or localized systemic infections. 4. The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}). 5. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study. 6. The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study. 7. The subject has used Retin A or Accutane within 6 months prior to enrollment. 8. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial. 9. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate). 10. The subject has a history of keloids. 11. The subject has evidence of compromised wound healing. 12. The subject has a history of squamous cell carcinoma or melanoma. 13. The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder. 14. The subject has an allergy to lidocaine and epinephrine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Photographic Evaluation of Wrinkle Severity at Baseline | Baseline | Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis. |
| Photographic Evaluation of Wrinkle Severity at 1 Month Post Last Treatment | 1 Month Follow Up Post Last Treatment | Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis. |
| Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up Post Last Treatment | 3 Month Follow Up Post Last Treatment | Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis. |
| Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up Post Last Treatment | 4 Month Follow Up Post Last Treatment | Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis. |
| Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up Post Last Treatment | 6 Month Follow Up Post Last Treatment | Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis. |
Other
| Measure | Time frame |
|---|---|
| Satisfaction Questionnaire | up to 6 months post last treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 755nm Alexandrite Laser 755nm Alexandrite Laser
755nm Alexandrite Laser: 755nm Alexandrite Laser for the treatment of Wrinkles | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | 755nm Alexandrite Laser |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Fitzpatrick Skin Type Score I | 4 Participants |
| Fitzpatrick Skin Type Score II | 15 Participants |
| Fitzpatrick Skin Type Score III | 1 Participants |
| Fitzpatrick Skin Type Score IV | 0 Participants |
| Fitzpatrick Skin Type Score V | 0 Participants |
| Fitzpatrick Skin Type Score VI | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 19 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 1 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 19 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Photographic Evaluation of Wrinkle Severity at 1 Month Post Last Treatment
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.
Time frame: 1 Month Follow Up Post Last Treatment
Population: One subject was unable to return to clinic for the 1 month visit due to a family emergency.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 755nm Alexandrite Laser | Photographic Evaluation of Wrinkle Severity at 1 Month Post Last Treatment | 4.74 score on a scale | Standard Deviation 0.991 |
Primary
Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up Post Last Treatment
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.
Time frame: 3 Month Follow Up Post Last Treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 755nm Alexandrite Laser | Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up Post Last Treatment | 4.25 score on a scale | Standard Deviation 1.07 |
Primary
Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up Post Last Treatment
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.
Time frame: 4 Month Follow Up Post Last Treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 755nm Alexandrite Laser | Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up Post Last Treatment | 3.9 score on a scale | Standard Deviation 1.07 |
Primary
Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up Post Last Treatment
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.
Time frame: 6 Month Follow Up Post Last Treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 755nm Alexandrite Laser | Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up Post Last Treatment | 4 score on a scale | Standard Deviation 1.21 |
Primary
Photographic Evaluation of Wrinkle Severity at Baseline
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 755nm Alexandrite Laser | Photographic Evaluation of Wrinkle Severity at Baseline | 5.25 score on a scale | Standard Deviation 0.851 |
Other Pre-specified
Satisfaction Questionnaire
Time frame: up to 6 months post last treatment