Acne Scars - Mixed Atrophic and HypertrophicNCT06102343
Safety and Efficacy Investigation on the Effects of ClearSkin Non-ablative ER:Glass 1540nm Laser Module in the Treatment of Acne Scars.
A study testing Alma Harmony in people with Acne Scars - Mixed Atrophic and Hypertrophic, run by Alma Lasers at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Scars - Mixed Atrophic and Hypertrophic
- What is being tested?
- Alma Harmony
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2024to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Up Clinic
Lisbon, 1400-020
Tiago Baptista, MD, +351960041855, tiagobf@hotmail.com
Tiago Baptista, MD
About this study
Official title: 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.
- Being tested
- Alma Harmony
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alma HarmonyDevice
Also called ClearSkin applicator
Acne scars treatment using non-ablative ER:Glass 1540 nm laser module.
| Study group | Role | What they receive |
|---|---|---|
| acne scars treatment using the Alma Harmony platform with the ClearSkin applicator. | Experimental | treatment of acne scars using the ClearSkin non-ablative ER:Glass 1540nm laser Module. Receives: Device: Alma Harmony |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of at least 6 points in Goodman Baron's score at 3-month follow-up visit compared to baseline.
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.
Measured: throughout the study, up to 1 year.
Secondary outcomes (6)
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.
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.
Measured: 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.
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.
Measured: throughout the study, up to 1 year.
Improvement in skin texture of the treated facial acne scars.
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.
Measured: throughout the study, up to 1 year.
Participant's satisfaction rates
Participant's satisfaction with treatment with the investigational devices using a 5-point Likert scale, at 1- and 3-month follow-up visits.
Measured: throughout the study, up to 1 year.
Adverse Events frequency & intensity.
Adverse Events frequency \& intensity, occurring at any time during the trial or follow-up periods.
Measured: throughout the study, up to 1 year.
Pain level rates
Pain level using NPRS, as evaluated at each treatment visit at the end of each treatment session.
Measured: throughout the study, up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne Scars - Mixed Atrophic and HypertrophicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alma Lasers
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tiago Baptista, MD, Principal investigator, Head of Up Clinic, Lisbon, Portugal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102343
- Sponsor's protocol ID
- ALM-HAR-CLS-23-01
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Safety, and Efficacy Investigation on the Effects of ClearSkin Non-ablative ER: Glass 1540nm Laser Module in the Treatment of Acne Scars.
- ClinicalTrials.gov ID
- NCT06102343
- Acronym / sponsor ID
- ALM-HAR-CLS-23-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Alma LasersIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acne scars treatment using the Alma Harmony platform with the ClearSkin applicator. | Experimental | Device: Alma Harmonytreatment of acne scars using the ClearSkin non-ablative ER:Glass 1540nm laser Module. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alma HarmonyAlso: ClearSkin applicatorAcne scars treatment using non-ablative ER:Glass 1540 nm laser module. | Device | acne scars treatment using the Alma Harmony platform with the ClearSkin applicator. |
Primary outcome
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.
6 secondary outcomes
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.
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 skin texture of the treated facial acne scars.
Time frame: throughout the study, up to 1 year.
Participant's satisfaction rates
Time frame: throughout the study, up to 1 year.
Adverse Events frequency & intensity.
Time frame: throughout the study, up to 1 year.
Pain level rates
Time frame: throughout the study, up to 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
Related trials for Acne Scars - Mixed Atrophic and Hypertrophic
Recruiting
Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
Acne Scars - Mixed Atrophic and Hypertrophic, Hyperpigmentation
Recruiting
AVAVA MIRIA General Use
Acne, Acne Scars - Mixed Atrophic and Hypertrophic
Active, not recruiting
Comparative Effects Of Trichloroacetic Chemical Peel And Fractional Laser
Melasma, Acne Scars - Mixed Atrophic and Hypertrophic
Active, not recruiting
AV-23-001 AVAVA MIRIA Pilot Study
Wrinkle, Acne Scars - Mixed Atrophic and Hypertrophic
Active, not recruiting
The MIRIA Acne Scar Study
Acne Scars - Mixed Atrophic and Hypertrophic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiago Baptista, MD principal investigator
Head of Up Clinic, Lisbon, Portugal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alma Harmony in people with Acne Scars - Mixed Atrophic and Hypertrophic, run by Alma Lasers at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natalie Dror, PhD (+972528264282, natalie.dror@almalasers.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.