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| Name | Class |
|---|---|
| Acclaro Corporation | UNKNOWN |
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To assess the efficacy, safety, and patient satisfaction associated with the treatment of the face and neck with the 2,910nm mid-infrared UltraClear Laser System using both superficial epidermal ablation and deep ablative and coagulative capabilities in the dermis for rejuvenation of photodamaged skin. Additionally, this study will assess the additive value of a post-treatment skincare regimen consisting of a serum and cream containing red deer umbilical cord lining mesenchymal stem cell conditioned media for faster healing and more robust rejuvenation.
Subjects will be treated with the UltraClear 2,910nm mid-infrared laser using both superficial epidermal ablation and deep ablative and coagulative capabilities in the dermis for rejuvenation of photodamaged skin of the face and neck. Subjects will be randomized to have one of two post-laser skincare regimens which will be applied to the face and neck following laser treatment.
All subjects will receive three (3) laser treatments to the face and neck using the UltraClear 2,910nm mid-infrared laser, performed 5 weeks ± 7 days apart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A CeraVe | Active Comparator | Subjects will be given a skincare regimen consisting of CeraVe products to be applied to the face and neck following laser treatment. |
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| Group B Calecim | Sham Comparator | Subjects will be given a skincare regimen consisting of CeraVe products and Calecim products to be applied to the face and neck following laser treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CeraVe | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale to assess change (blinded investigator) | Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale - FACE TO BE COMPLETED BY BLINDED INVESTIGATOR Class: Wrinkling Score Degree of Elastosis I Fine Wrinkles 1 -3 Mild II Fine to Moderate 4 -6 Moderate III Fine to Deep 7 -9 Severe | Baseline, Day 60, Day 250 |
| Scientific Assessment Scale of Skin Quality to assess change (SASSQ) (blinded investigator) | SCIENTIFIC ASSESSMENT SCALE OF SKIN QUALITY (SASSQ) Elasticity: 0-None 1-Mild 2-Moderate 3-Severe 4-Very Severe Wrinkles: 0-None 1-Mild 2-Moderate 3-Severe 4-Very Severe Skin Surface Roughness: 0-None 1-Mild 2-Moderate 3-Severe 4-Very Severe Pigmentation: 0-None 1-Mild 2-Moderate 3-Severe 4-Very Severe Erythema: 0-None 1-Mild 2-Moderate 3-Severe 4-Very Severe Pore Size: 0-None 1-Mild 2-Moderate 3-Severe 4-Very Severe | Baseline, Day 160, Day 250 |
| Classification of Facial Wrinkles Assessment to assess change (blinded investigator) | Classification of Facial Wrinkles Assessment: Preauricular Lines: 0-None 1-Very Mild 2-Mild 3-Moderate 4-Severe 5-Extreme Cheek Folds: 0-None 1-Very Mild 2-Mild 3-Moderate 4-Severe 5-Extreme Upper Lip Lines: 0-None 1-Very Mild 2-Mild 3-Moderate 4-Severe 5-Extreme | Baseline, Day 160, Day 250 |
| Neck Skin Crepiness/Laxity Grading Scale to assess change (blinded investigator) | Neck Skin Crepiness/Laxity Grading Scale: Score Classification Description 0 None No Loose Skin
| Baseline, Day 160, Day 250 |
| Visia Skin Analysis to assess change | Visia Skin Analysis (insert percentage 1 - 100%) Description: Percentage: Brown Spots Pores Spots Porphyrin Red Areas Texture UV Spots Wrinkles |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of side effects and adverse events by Investigator to assess change | Evaluation of Side Effects and Adverse Events: Rating Description 0 NONE: Normal
SCORES (write number under each treated area or check "Not Treated") Erythema: FACE NECK Edema: FACE NECK Hyperpigmentation: FACE NECK Blistering: FACE NECK Burn: FACE NECK Skin Crusting: FACE NECK |
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Inclusion Criteria:
Adult males and females aged 18 to 75 years
Fitzpatrick skin types I-V
Subjects in good general health based on investigator's judgment and medical history
Must be willing to give and sign an informed consent form and photographic release form
Willingness to have examinations of face and neck and digital photographs performed of the face and neck
Physician evaluator classifying the subject as moderate to severe (Class II-III, Score 4-9) on the Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale for the face and neck.
The subject must be planning to undergo fractional ablative laser resurfacing to the face and neck and be willing to comply with study protocol and complete the entire course of the study.
Subjects using any treatment skincare products (per investigator discretion) must discontinue use of these products before the start of participating in this clinical study and for the duration of the study.
Male subjects with facial hair must be willing to shave the morning of the procedure.
Must be willing to maintain usual sun exposure
Subject agrees to avoid tanning or use of sunless tanner during the entire course of the study
Negative urine pregnancy test result at the time of study entry (if applicable)
For female subjects of childbearing potential, must be willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment.
Must be willing to comply with study treatments and complete the entire course of the study
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Pacheco | Contact | 858-657-1004 | apacheco@clderm.com | |
| Freia Canals Cistero, RN | Contact |
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| ID | Term |
|---|---|
| D008548 | Melanosis |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Subjects will be randomized to have one of two post-laser skincare regimens which will be applied to the face and neck following laser treatment.
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The blinded investigator will complete the - Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale of face and neck, the Scientific Assessment Scale of Skin Quality (SASSQ) to grade the subject's skin quality of face and neck, the Classification of Facial Wrinkles Assessment and the Blinded Investigator Neck Skin Crepiness/Laxity Grading Scale.
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| CeraVe and Calecim | Other |
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| Baseline, Day 160, Day 250 |
| Physician Global Aesthetic Improvement Scale to assess change (PGAIS) (blinded investigator) | Physician Global Aesthetic Improvement Scale Assessment (PGAIS) Rating Description
Scores (write a number under each treated area or circle "Not Treated") FACE NECK not treated not treated | Day 160, Day 250 |
| Percent Improvement Evaluation to assess change | Percent Improvement Evaluation: Degree of improvement from clinical evaluation, compare to baseline, using a 1-10 scale. 1 (0-10%) 2 (10-20%) 3 (20-30%) 4(30-40%) 5 (40-50%) 6 (50-60%) 7 (60-70%) 8 (70-80%) 9 (80-90%) 10 (90-100%) | Day 160, Day 250 |
| Baseline, Day 35, Day 70, Day 160, Day 250 |
| Comfort Level Visual Analog Scale post laser procedure to assess change (completed by subject) | Comfort Level Visual Analog Scale post laser procedure (circle one) Face: No Pain Moderate Pain Worst Pain 0 1 2 3 4 5 6 7 8 9 10 Neck: No Pain Moderate Pain Worst Pain 0 1 2 3 4 5 6 7 8 9 10 | Baseline, Day 35, Day 70 |
| Subject Global Aesthetic Improvement Scale to assess change (SGAIS) | Subject Global Aesthetic Improvement Scale Assessment (SGAIS) Rating Description
Scores (write a number under each treated area or circle Not Treated) FACE NECK not treated not treated | Day 160, Day 250 |
| Subject Satisfaction Questionnaire to assess change | Subject Satisfaction Questionnaire How would you rate your satisfaction of each treated area? Non-treated areas will be checked as "Not Treated" for you. Rating Description 0 Not satisfied
Scores (write a number to rate each treated area) FACE NECK not treated not treated | Day 160, Day 250 |