Safety and Efficacy Investigation on the Effects of ClearSkin Non-ablative ER:Glass 1540nm Laser Module in the Treatment of Acne Scars.

October 21, 2023 updated by: Alma Lasers

Open-label, Safety, and Efficacy Investigation on the Effects of ClearSkin Non-ablative ER: Glass 1540nm Laser Module in the Treatment of Acne Scars.

The ClearSkin module, Er: Glass 1540nm, is largely used in the treatment of acne vulgaris and acne scars. The non-ablative ER:Glass 1540 nm laser deeply penetrates the skin, causing thermal damage to the sebaceous glands, destroying P. acnes bacteria and reducing sebum production, while leaving the epidermis intact. The integrated vacuum mechanism extracts accumulated sebaceous material from the pores, while contact cooling protects the skin, reducing pain and allowing for safer and more effective treatment of the sebaceous glands within the dermis. Based on this background, the investigators have considered a pilot study aimed at assessing the efficacy and safety of the ClearSkin Module in treating subjects with facial acne scars.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Portugal
      • Lisboa, Portugal, 1400-020
        • Up Clinic
        • Contact:
        • Principal Investigator:
          • Tiago Baptista, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Men or women aged 18 to 50 years
  • Presence of mild to moderate facial acne scars (according to Goodman & Baron's scale)
  • Subjects in reasonably good general health, according to the Investigator's judgment;
  • Subjects who agree to avoid tanning during the entire investigational period;
  • Subjects who agree to avoid any other facial procedure during the entire investigational period; including but not limited to: injectables or threads, peeling of any kind, dermabrasion, facial hair removal, or application of any cosmeceutical/pharmaceutical without the consent from the PI only.
  • Subjects able to understand the full nature and the purpose of the investigation, including possible risks and side effects, able to cooperate with the Investigator and comply with the requirements of the entire investigation (ability to attend all the planned investigation visits according to the time limits included) based on Investigator's judgment.
  • Subjects willing to sign an informed consent, consent to use their photos for future scientific or marketing purposes, according to the sponsor's needs.

Exclusion Criteria:

  • Subjects with active infections
  • Subjects with a history of keloid scarring or hypertrophic scar formation
  • Subjects with previous medical treatment of the area, or oral retinoid drug prescribed within the past six months
  • Subjects who have been tanning within the past 30 days;
  • Previous surgical treatment of the area selected for the treatment with the investigational device;
  • Subjects with any inflammatory skin condition e.g., eczema, active herpes simplex, etc. at the treatment site;
  • Subjects with the presence of tattoos at the treatment site
  • Subjects with skin cancer or any other cancer and/or any cancer drug therapy (such as ducabaxine, fluorouracil, methotrexate, etc.)
  • Subjects with history of autoimmune disorder or evidence of immunosuppression;
  • Subjects with collagen vascular diseases
  • Subjects with thrombocytopenia
  • Subjects with peripheral vascular disease
  • Subjects with Melasma
  • Pregnant or lactating subjects

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: acne scars treatment using the Alma Harmony platform with the ClearSkin applicator.
treatment of acne scars using the ClearSkin non-ablative ER:Glass 1540nm laser Module.
Device: Alma Harmony
Acne scars treatment using non-ablative ER:Glass 1540 nm laser module.
Other Names:
  • ClearSkin applicator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reduction of at least 6 points in Goodman Baron's score at 3-month follow-up visit compared to baseline.
Time Frame: throughout the study, up to 1 year.
comparison of acne scars' Goodman Baron's score at baseline with acne scars' Goodman Baron's score at 3-month follow-up visit compared to baseline.
throughout the study, up to 1 year.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Improvement in the treated facial acne scars after ClearSkin according to the General Aesthetic Improvement Scale (GAIS), at the 3-month follow-up visit compared to baseline.
Time Frame: throughout the study, up to 1 year.
70% of participants will demonstrate any improvement in the treated facial acne scars after ClearSkinTM according to the General Aesthetic Improvement Scale (GAIS), at the 3-month follow-up visit compared to baseline, as evaluated by three blinded assessors. The evaluation will be performed by means of the examination of the photography of treated facial acne scars performed using 2D photographs.
throughout the study, up to 1 year.
Improvement in the treated facial acne scars after ClearSkin according to the General Aesthetic Improvement Scale (GAIS), at the 1-month follow-up visit compared to baseline.
Time Frame: throughout the study, up to 1 year.
Improvement in aesthetic appearance of the treated facial acne scars, as assessed by the principal investigator according to the General Aesthetic Improvement Scale (GAIS) at the 1-month follow-up visit compared to baseline. The evaluation will be performed by means of the examination of the photography of all treated facial acne scars performed using 2D photographs.
throughout the study, up to 1 year.
Improvement in skin texture of the treated facial acne scars.
Time Frame: throughout the study, up to 1 year.
Improvement in skin texture of the treated facial acne scars, as evaluated by the 3D pictures taken at the 1- and 3-month follow-up visits compared to baseline.
throughout the study, up to 1 year.
Participant's satisfaction rates
Time Frame: throughout the study, up to 1 year.
Participant's satisfaction with treatment with the investigational devices using a 5-point Likert scale, at 1- and 3-month follow-up visits.
throughout the study, up to 1 year.
Adverse Events frequency & intensity.
Time Frame: throughout the study, up to 1 year.
Adverse Events frequency & intensity, occurring at any time during the trial or follow-up periods.
throughout the study, up to 1 year.
Pain level rates
Time Frame: throughout the study, up to 1 year.
Pain level using NPRS, as evaluated at each treatment visit at the end of each treatment session.
throughout the study, up to 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alma Lasers

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tiago Baptista, MD, Head of Up Clinic, Lisbon, Portugal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALM-HAR-CLS-23-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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