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Trial record 46 of 82 for:    acne AND Acne Scars

Evaluation of the Cutera Enlighten™ Laser With Micro-Lens Array (MLA) Handpiece Attachment

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ClinicalTrials.gov Identifier: NCT03430921
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Cutera Inc.

Brief Summary:
The purpose of this pivotal investigation is to evaluate the efficacy and safety of the Cutera enlighten multi-wavelength 532 nm and 1064 nm Nd:YAG picosecond pulse duration laser and an investigational micro-lens array (MLA) handpiece attachment for improvement of moderate to severe acne scars.

Condition or disease Intervention/treatment Phase
Scarring Acne Device: Enlighten™ Laser and a MLA Attachment Not Applicable

Detailed Description:
This is an open-label, prospective, multicenter, pivotal study in approximately 15 male or female subjects, age 18 to 65 years who desire laser treatment for the improvement of moderate to severe acne scars. Subjects will receive up to 6 laser treatments, spaced 6 weeks (± 2 weeks) apart with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment. Subjects may undergo a 2mm punch biopsy before, immediately after and up to 72 hours after treatment. Subjects will be contacted by phone 7 days (± 2 days) after their first treatment for follow-up. Subjects will return to the site after all study treatments have been delivered for two follow-up visits: 6 and 12 weeks (± 2 weeks) following their final study treatment and may receive a biopsy per Investigator discretion either at one of these visits or 3 months post initial treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Prospective, Multicenter Study to Evaluate the Cutera Enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the Treatment of Moderate to Severe Acne Scars
Actual Study Start Date : August 15, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
Enlighten™ Laser and a MLA Attachment
Enlighten™ Laser and a Micro-Lens Array Handpiece Attachment
Device: Enlighten™ Laser and a MLA Attachment
Subjects will receive up to six treatments with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment, and may undergo a 2mm punch biopsy before, immediately after, and up to 72 hours after treatment. Subjects may receive a biopsy per Investigator discretion either at one of the follow-up visits (6 weeks or 12 weeks) or 3 months post initial treatment.




Primary Outcome Measures :
  1. Positive change from Baseline at 12 weeks post final treatment [ Time Frame: Baseline, and 12 weeks post final treatment ]
    Accurate Temporal Photo Identification of the Baseline and 12 weeks post final treatment pair, by at least two of the three blinded reviewers in 75% of the patients.

  2. Acne Scarring Improvement [ Time Frame: Baseline, and at 12 weeks post final treatment ]
    An improvement in Acne Scarring of at least one point on the Acne Scar Assessment Scale (ASAS):(1=clear scarring, 2=Very Mild scarring, 3=Mild scarring, 4=Moderate scarring or 5=Severe scarring) at the 12 weeks post final treatment by at least two of the three blinded reviewers in 75% of the patients.


Secondary Outcome Measures :
  1. Acne Scarring Assessment [ Time Frame: Baseline, post-treatment #2 through study completion, an average of 1 year, 6 weeks post final treatment and 12 weeks post final treatment ]
    Measuring the efficacy of Cutera enLighten device with MLA handpiece attachment for Acne scarring Improvement as assessed by Investigator using the Acne Scar Assessment Scale (ASAS):(1=clear, 2=Very Mild, 3=Mild, 4=Moderate or 5=Severe) after 2nd treatment, and every treatment thereafter, at 6 weeks post final treatment and 12 weeks post final treatment

  2. Physician's Global Assessment [ Time Frame: post-treatment #2 through study completion, an average of 1 year, 6 weeks post final treatment and 12 weeks post final treatment ]
    Measuring the efficacy of Cutera enLighten device with MLA handpiece attachment for improvement of the overall skin quality as assessed by Investigator using the Physician's Global Aesthetic Improvement Scale: +3=Significant Improvement (66 - 100%), +2=Moderate Improvement(36 - 65%), +1=Mild Improvement(1 - 35%) and 0=No Change(0%) after 2nd treatment, and every treatment thereafter, 6 weeks post final treatment and 12 weeks post final treatment

  3. Skin Quality Assessment [ Time Frame: Baseline, and post-treatment #2 through study completion, an average of 1 year, 6 weeks post final treatment and 12 weeks post final treatment ]
    Measuring the efficacy of Cutera enLighten device with MLA handpiece attachment for Skin quality as assessed by Investigator using Skin Quality Rating for Radiance(1=No radiance to 10=Maximum radiance), Smoothness(1=Very Rough to 10=Very Smooth), Pigmentation(1=Very irregular pigmentation to 10=Very uniform pigmentation), Erythema(1=Intense redness to 10=No redness) and Pore size(1=Very large pores to 10=Minimal pores) after 2nd treatment, and every treatment thereafter, 6 weeks post final treatment and 12 weeks post final treatment

  4. Subject Assessment of Acne scar Treatment [ Time Frame: 12 week post final treatment ]
    Satisfaction level and assessment of Acne Scar improvement as assessed by Subject: Where 2 = Extremely Satisfied, 1=Satisfied, 0=Neutral, -1=Unsatisfied; and -2=Extremely Unsatisfied at 12 weeks post final treatment.

  5. Histological Evaluation of tissue, if taken [ Time Frame: Biopsy times are: Baseline (untreated), and immediately (or up to 72 hours) after any one treatment, or 3 months post initial treatment ]
    Histological evaluation of tissue from biopsies of treated vs. untreated



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject must be able to read, understand and sign the Informed Consent Form.
  2. Female or Male, 18 to 65 years of age (inclusive).
  3. Fitzpatrick Skin Type I - VI (Appendix 6).
  4. Subject desires treatment for acne scars and wishes to undergo laser treatments for improvement.
  5. Subject has bilateral moderate to severe signs of facial acne scarring.
  6. Must be willing to have Cutera enlighten laser with the Micro-Lens Array handpiece attachment treatments and able to adhere to the treatments, follow-up visit schedule, and post-treatment care instructions.
  7. Willing to have very limited sun exposure and use sunscreen on the treatment area every day for the duration of the study, including the follow-up period.
  8. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation (educational and/or marketing), publications, and any additional marketing purposes.
  9. Agree to not undergo any other procedure(s) or treatment(s) for acne scars during the study and has no intention of having such procedures performed during the course of the study.
  10. For female subjects: not pregnant or lactating and is either post-menopausal, 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.,

Exclusion Criteria:

  1. Participation in a clinical trial of another drug, or device administered to the treatment area, within 6 months prior to enrollment or during the study.
  2. Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser procedures, facial fillers, i.e. (Bellafill) and those used for general aesthetic correction, facial peel, lightening creams, or facial surgery.
  3. Use of prescription topicals in the treatment area within one month prior to treatment or use of topical agents one week prior to treatment that may cause facial sensitivity.
  4. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including but not limited to, open lacerations or abrasions, hidradenitis, rash, infection , or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion).
  5. Pregnant and/or breastfeeding, or planning to become pregnant.
  6. Significant concurrent illness, such as diabetes mellitus, immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or using immunosuppressive medication.
  7. Hypersensitivity to light exposure.
  8. Any use of medication that is known to increase sensitivity to light according to the Investigator's discretion.
  9. History of keloid scarring, hypertrophic scarring or abnormal wound healing or prone to bruising.
  10. Has a history of squamous cell carcinoma or melanoma in the treatment area.
  11. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders.
  12. A history or active skin condition that in the opinion of the Investigator may interfere/confound with the treatment.
  13. History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
  14. 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.
  15. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation, or any that are considered not acceptable by the study investigator.
  16. Has used oral isotretinoin (Accutane or therapeutic vitamin A supplements of ≥ 10,000 units per day) within 12 months of initial treatment or plans on using during the course of the study (note: skin must regain its normal degree of moisture prior to treatment, e.g. lack of noticeable skin flaking and peeling).
  17. Excessively tanned or active sun tan in facial area to be treated, or unable/unlikely to refrain from tanning during the study.
  18. Excessive facial hair in the area to be treated (beards, sideburns, and/or moustache,) that would interfere with diagnosis, assessment, and treatment.
  19. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study, including excessive alcohol or drug abuses, or a condition that would compromise the subject's ability to comply with the study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430921


Contacts
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Contact: Michaela Bell 415-657-5722 mbell@cutera.com
Contact: Ginger Pocock 415-657-5702 gpocock@cutera.com

Locations
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United States, California
Cutera Research Center Recruiting
Brisbane, California, United States, 94005
Contact: Mischell San Juan    415-657-5544    msanjuan@cutera.com   
Sub-Investigator: Stephen Ronan, MD         
Sponsors and Collaborators
Cutera Inc.
Investigators
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Principal Investigator: Stephen Ronan, M.D. Cutera Research Center

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Responsible Party: Cutera Inc.
ClinicalTrials.gov Identifier: NCT03430921     History of Changes
Other Study ID Numbers: C-17-ML03
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes