AcneNCT05686603
Comparison of Picosecond Lasers vs. Ablative Fractional Er:YAG Lasers in Treating Atrophic Scar
A study testing a fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpiece and a ablative fractional 2940-nm Er:YAG laser in people with Acne and Atrophic Scar, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The 1064-nm Nd:YAG picosecond lasers using fractional micro-lens array (P-MLA) was a promising therapy for skin resurfacing. However, no studies have compared P-MLA with ablative fractional 2940-nm Er:YAG lasers (AF-Er) in treating atrophic acne scars. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne, Atrophic Scar
- What is being tested?
- a fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpiece and a ablative fractional 2940-nm Er:YAG laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2022to 31 Oct 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥18 years;
- presence with similar atrophic acne scars on both sides of the face;
- signed informed consent and cooperated with the follow up and complied the study protocol.
Who cannot join
- a previous history of keloid or hypertrophic scar formation;
- undergone any acne scar treatments in the past 6 months before the first treatment;
- pregnant or lactating females;
- sensitive to lights;
- allergic to lidocaine;
- other preexisting skin conditions or uncontrolled systemic diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310009
About this study
Official title: Comparison of 1064nm Nd:YAG Picosecond Lasers Using Fractional Micro-lens Array vs. Ablative Fractional 2940nm Er:YAG Lasers for the Treatment of Atrophic Acne Scar in Asians: a 20-week Prospective, Randomized, Split-face, Controlled Trial
The 1064-nm Nd:YAG picosecond lasers using fractional micro-lens array (P-MLA) was a promising therapy for skin resurfacing. However, no studies have compared P-MLA with ablative fractional 2940-nm Er:YAG lasers (AF-Er) in treating atrophic acne scars. To evaluate the efficacy and safety of P-MLA and AF-Er for the treatment of atrophic acne scars, we performed a prospective, randomized, split-face, controlled trial. Thirty-one Asian patients underwent four consecutive sessions of randomized split-face treatment with P-MLA and AF-Fr at 4-week intervals.
Read the detailed description
Acne is a common skin disorder affecting 9.38% of the global population, especially among adolescents and young adults. One publication showed that 43% of cases with facial acne could develop scars, and the acne-associated scarring often has a negative effect on patients' psychosocial and physical well-being. A wide range of interventions have been proposed to treat atrophic acne scars, including laser, chemical peels, dermabrasion, injectable fillers and surgical methods. Picosecond laser is a novel technology characterized by ultra-short, picosecond pulse duration which can be effective for many skin conditions, such as pigmentation, photoaging and wrinkles reduction. When combined with micro-lens array (MLA) optics, high-intensity, micro-injury zones can be generated in the epidermis and dermis, causing optical breakdown of surrounding tissue and stimulating of dermal remodeling with mild side-effects. However, there are insufficient prospective comparative studies evaluating the picosecond laser with MLA optics vs. current fractional ablative techniques for the treatment of atrophic acne scars.In this study, we reported a prospective, randomized, split-face, controlled trial that comparing the efficacy and safety of a fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpiece (P-MLA) and ablative fractional 2940-nm Er:YAG laser (AF-Er) for the treatment of atrophic acne scars in Asians.
- Study design This prospective, randomized, split-face, controlled trial was approved by the Human Ethics Committee of Zhejiang University School of Medicine Second Affiliated Hospital (2022-0419) and performed in accordance with the Declaration of Helsinki. Written informed consent was obtained from all subjects before enrollment.
- Patient selection A total of thirty-three subjects (16 males and 17 females) aged above 18 years of Fitzpatrick skin types II to type V, with mild to moderate atrophic acne scars were recruited for this study. Inclusion criteria for this study were as follows: (1) age ≥18 years; (2) presence with similar atrophic acne scars on both sides of the face; (3) signed informed consent and cooperated with the follow up and complied the study protocol. Subjects were excluded if they had a previous history of keloid or hypertrophic scar formation, undergone any acne scar treatments in the past 6 months before the first treatment, were pregnant or lactating females, were sensitive to lights, were allergic to lidocaine, had other preexisting skin conditions or uncontrolled systemic diseases.
- Treatment Enrolled participant was randomized to receive split-face treatment with fractional 1064-nm Nd:YAG picosecond lasers (PicocareTM, Wontech, Korea) on one side and ablative fractional 2940-nm Er:YAG laser (Dermablate MCL31, Asclepion Laser Technologies, Germany) on the other side. The block randomization was used to assign the treatment modality.
- Assessment Thorough history taking and physical examination were performed in all subjects. Efficacy and safety of the treatments were evaluated at each visit, and VISIA images (Visia CR®; Canfield Scientific, Parsippany, NJ, USA) of front, left and right face were also obtained at both baseline and last visit for final analyses.
Efficacy Efficacy of scar improvement was evaluated by investigators and patients. A blinded investigator assessed the clinical efficacy by the Echelle d'Evaluation Clinique des Cicatrices d'acne (ECCA) grading scale and Investigator's Global Assessment (IGA) scores. ECCA score is calculated on the sum of the number and type of scar (V-type, U-type and M-type)(13). IGA was evaluated using a 5-point scale as follows: 0 = no improvement; 1 = 1-25% improvement; 2 = 26-50% improvement; 3 = 51-75% improvement; 4 = 76-100% improvement. Patients rated their degree of satisfaction about scar improvement, pore, skin texture and overall improvement using a Likert satisfaction scale (1 = very dissatisfied, 2 = dissatisfied, 3 = slightly satisfied, 4 = satisfied, 5 = very satisfied). The primary endpoints were the change of ECCA score, IGA score and degree of patient's satisfaction at the final visit compared the baseline score. We also used VISIA system to evaluate the pore and skin texture objectively.
Safety Patients were evaluated at each session immediately for adverse effects including pain, erythema, edema, exudation, pinpoint bleeding and petechiae. The pain was evaluated using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (unbearable pain). Other immediate adverse effects were recorded with a 0-to-3 severity scale (0 = none; 1 = mild; 2 = moderate; 3 = severe). At next follow-up, patients were also asked to record and document their recovery times and possible long-term adverse effects, including crust shedding time, duration of erythema and edema, post inflammatory hyperpigmentation (PIH), scarring formation, pruritus and milia.
- Conditions
- Acne, Atrophic Scar
- Being tested
- a fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpiece, a ablative fractional 2940-nm Er:YAG laser
- Keywords
- atrophic scar, acne, picosecond laser, ablative laser, efficacy, safety
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpieceDevice
Picosecond laser is a novel technology characterized by ultra-short, picosecond pulse duration which can be effective for many skin conditions, such as pigmentation, photoaging and wrinkles reduction. When combined with micro-lens array (MLA) optics, high-intensity, micro-injury zones can be generated in the epidermis and dermis, causing optical breakdown of surrounding tissue and stimulating of dermal remodeling with mild side-effects. Previous studies had showed the picosecond lasers with MLA afforded better or similar clinical outcomes as well as fewer side-effects in treating acne scar than non-ablative lasers.
a ablative fractional 2940-nm Er:YAG laserDevice
2940-nm erbium yttrium aluminum garnet (Er:YAG) laser is one of the most commonly used treatments for atrophic acne scars, which can remove the damage tissue of the scars and allow collagen remodeling and re-epithelialization.
| Study group | Role | What they receive |
|---|---|---|
| P-MLA | Experimental | a fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpiece (P-MLA for short) Receives: Device: a fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpiece |
| AF-Er | Sham comparator | ablative fractional 2940-nm Er:YAG laser (AF-Er for short) Receives: Device: a ablative fractional 2940-nm Er:YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of scar improvement evaluated by investigators
the Echelle d'Evaluation Clinique des Cicatrices d'acne (ECCA) grading scale and Investigator's Global Assessment (IGA) scores
Measured: 8 weeks after final treatment
Efficacy of scar improvement evaluated by patients
a Likert satisfaction scale (1 = very dissatisfied, 2 = dissatisfied, 3 = slightly satisfied, 4 = satisfied, 5 = very satisfied)
Measured: 8 weeks after final treatment
Secondary outcomes (2)
Adverse effects of pain, erythema, edema, exudation, pinpoint bleeding and petechiae
Pain, erythema, edema, exudation, pinpoint bleeding and petechiae
Measured: Immediately after treatment.
Adverse effects of crust shedding time, duration of erythema and edema, post inflammatory hyperpigmentation (PIH), scarring formation, pruritus and milia.
crust shedding time, duration of erythema and edema, post inflammatory hyperpigmentation (PIH), scarring formation, pruritus and milia.
Measured: Through study completion, 8 weeks after final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start12 Apr 2022
- Primary completion30 Sep 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- This prospective, randomized, split-face, controlled trial. Enrolled participant was randomized to receive split-face treatment with fractional 1064-nm Nd:YAG picosecond lasers (PicocareTM, Wontech, Korea) on one side and ablative fractional 2940-nm Er:YAG laser (Dermablate MCL31, Asclepion Laser Technologies, Germany) on the other side. The block randomization was used to assign the treatment modality.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dai Ru, Ph.D, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686603
- Sponsor's protocol ID
- 20220419
- Status last verified
- Apr 2022
- First submitted
- 9 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dai R, Cao Y, Su Y, Cai S. Comparison of 1064-nm Nd:YAG picosecond laser using fractional micro-lens array vs. ablative fractional 2940-nm Er:YAG laser for the treatment of atrophic acne scar in Asians: a 20-week prospective, randomized, split-face, controlled pilot study. Front Med (Lausanne). 2023 Nov 16;10:1248831. doi: 10.3389/fmed.2023.1248831. eCollection 2023.
PubMed 38034535
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 1064nm Nd:YAG Picosecond Lasers Using Fractional Micro-lens Array vs. Ablative Fractional 2940nm Er:YAG Lasers for the Treatment of Atrophic Acne Scar in Asians: a 20-week Prospective, Randomized, Split-face, Controlled Trial
- ClinicalTrials.gov ID
- NCT05686603
- Acronym / sponsor ID
- 20220419
- Conditions
- Acne, Atrophic Scar
- Keywords
- atrophic scar, acne, picosecond laser, ablative laser, efficacy, safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 17 Jan 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 1064-nm Nd:YAG picosecond lasers using fractional micro-lens array (P-MLA) was a promising therapy for skin resurfacing. However, no studies have compared P-MLA with ablative fractional 2940-nm Er:YAG lasers (AF-Er) in treating atrophic acne scars. To evaluate the efficacy and safety of P-MLA and AF-Er for the treatment of atrophic acne scars, we performed a prospective, randomized, split-face, controlled trial. Thirty-one Asian patients underwent four consecutive sessions of randomized split-face treatment with P-MLA and AF-Fr at 4-week intervals.
Detailed description
Acne is a common skin disorder affecting 9.38% of the global population, especially among adolescents and young adults. One publication showed that 43% of cases with facial acne could develop scars, and the acne-associated scarring often has a negative effect on patients' psychosocial and physical well-being. A wide range of interventions have been proposed to treat atrophic acne scars, including laser, chemical peels, dermabrasion, injectable fillers and surgical methods. Picosecond laser is a novel technology characterized by ultra-short, picosecond pulse duration which can be effective for many skin conditions, such as pigmentation, photoaging and wrinkles reduction. When combined with micro-lens array (MLA) optics, high-intensity, micro-injury zones can be generated in the epidermis and dermis, causing optical breakdown of surrounding tissue and stimulating of dermal remodeling with mild side-effects. However, there are insufficient prospective comparative studies evaluating the picosecond laser with MLA optics vs. current fractional ablative techniques for the treatment of atrophic acne scars.In this study, we reported a prospective, randomized, split-face, controlled trial that comparing the efficacy and safety of a fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpiece (P-MLA) and ablative fractional 2940-nm Er:YAG laser (AF-Er) for the treatment of atrophic acne scars in Asians.
- Study design This prospective, randomized, split-face, controlled trial was approved by the Human Ethics Committee of Zhejiang University School of Medicine Second Affiliated Hospital (2022-0419) and performed in accordance with the Declaration of Helsinki. Written informed consent was obtained from all subjects before enrollment.
- Patient selection A total of thirty-three subjects (16 males and 17 females) aged above 18 years of Fitzpatrick skin types II to type V, with mild to moderate atrophic acne scars were recruited for this study. Inclusion criteria for this study were as follows: (1) age ≥18 years; (2) presence with similar atrophic acne scars on both sides of the face; (3) signed informed consent and cooperated with the follow up and complied the study protocol. Subjects were excluded if they had a previous history of keloid or hypertrophic scar formation, undergone any acne scar treatments in the past 6 months before the first treatment, were pregnant or lactating females, were sensitive to lights, were allergic to lidocaine, had other preexisting skin conditions or uncontrolled systemic diseases.
- Treatment Enrolled participant was randomized to receive split-face treatment with fractional 1064-nm Nd:YAG picosecond lasers (PicocareTM, Wontech, Korea) on one side and ablative fractional 2940-nm Er:YAG laser (Dermablate MCL31, Asclepion Laser Technologies, Germany) on the other side. The block randomization was used to assign the treatment modality.
- Assessment Thorough history taking and physical examination were performed in all subjects. Efficacy and safety of the treatments were evaluated at each visit, and VISIA images (Visia CR®; Canfield Scientific, Parsippany, NJ, USA) of front, left and right face were also obtained at both baseline and last visit for final analyses.
Efficacy Efficacy of scar improvement was evaluated by investigators and patients. A blinded investigator assessed the clinical efficacy by the Echelle d'Evaluation Clinique des Cicatrices d'acne (ECCA) grading scale and Investigator's Global Assessment (IGA) scores. ECCA score is calculated on the sum of the number and type of scar (V-type, U-type and M-type)(13). IGA was evaluated using a 5-point scale as follows: 0 = no improvement; 1 = 1-25% improvement; 2 = 26-50% improvement; 3 = 51-75% improvement; 4 = 76-100% improvement. Patients rated their degree of satisfaction about scar improvement, pore, skin texture and overall improvement using a Likert satisfaction scale (1 = very dissatisfied, 2 = dissatisfied, 3 = slightly satisfied, 4 = satisfied, 5 = very satisfied). The primary endpoints were the change of ECCA score, IGA score and degree of patient's satisfaction at the final visit compared the baseline score. We also used VISIA system to evaluate the pore and skin texture objectively.
Safety Patients were evaluated at each session immediately for adverse effects including pain, erythema, edema, exudation, pinpoint bleeding and petechiae. The pain was evaluated using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (unbearable pain). Other immediate adverse effects were recorded with a 0-to-3 severity scale (0 = none; 1 = mild; 2 = moderate; 3 = severe). At next follow-up, patients were also asked to record and document their recovery times and possible long-term adverse effects, including crust shedding time, duration of erythema and edema, post inflammatory hyperpigmentation (PIH), scarring formation, pruritus and milia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This prospective, randomized, split-face, controlled trial. Enrolled participant was randomized to receive split-face treatment with fractional 1064-nm Nd:YAG picosecond lasers (PicocareTM, Wontech, Korea) on one side and ablative fractional 2940-nm Er:YAG laser (Dermablate MCL31, Asclepion Laser Technologies, Germany) on the other side. The block randomization was used to assign the treatment modality.
| Arm | Type | Receives |
|---|---|---|
| P-MLA | Experimental | Device: a fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpiecea fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpiece (P-MLA for short) |
| AF-Er | Sham comparator | Device: a ablative fractional 2940-nm Er:YAG laserablative fractional 2940-nm Er:YAG laser (AF-Er for short) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥18 years;
- presence with similar atrophic acne scars on both sides of the face;
- signed informed consent and cooperated with the follow up and complied the study protocol.
Key exclusion criteria (6 listed)
- a previous history of keloid or hypertrophic scar formation;
- undergone any acne scar treatments in the past 6 months before the first treatment;
- pregnant or lactating females;
- sensitive to lights;
- allergic to lidocaine;
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 |
|---|---|---|
| a fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpiecePicosecond laser is a novel technology characterized by ultra-short, picosecond pulse duration which can be effective for many skin conditions, such as pigmentation, photoaging and wrinkles reduction. When combined with micro-lens array (MLA) optics, high-intensity, micro-injury zones can be generated in the epidermis and dermis, causing optical breakdown of surrounding tissue and stimulating of dermal remodeling with mild side-effects. Previous studies had showed the picosecond lasers with MLA afforded better or similar clinical outcomes as well as fewer side-effects in treating acne scar than non-ablative lasers. | Device | P-MLA |
| a ablative fractional 2940-nm Er:YAG laser2940-nm erbium yttrium aluminum garnet (Er:YAG) laser is one of the most commonly used treatments for atrophic acne scars, which can remove the damage tissue of the scars and allow collagen remodeling and re-epithelialization. | Device | AF-Er |
Primary outcome
Efficacy of scar improvement evaluated by investigators
Time frame: 8 weeks after final treatment
the Echelle d'Evaluation Clinique des Cicatrices d'acne (ECCA) grading scale and Investigator's Global Assessment (IGA) scores
Efficacy of scar improvement evaluated by patients
Time frame: 8 weeks after final treatment
a Likert satisfaction scale (1 = very dissatisfied, 2 = dissatisfied, 3 = slightly satisfied, 4 = satisfied, 5 = very satisfied)
2 secondary outcomes
Adverse effects of pain, erythema, edema, exudation, pinpoint bleeding and petechiae
Time frame: Immediately after treatment.
Adverse effects of crust shedding time, duration of erythema and edema, post inflammatory hyperpigmentation (PIH), scarring formation, pruritus and milia.
Time frame: Through study completion, 8 weeks after final treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 38034535Dai R, Cao Y, Su Y, Cai S. Comparison of 1064-nm Nd:YAG picosecond laser using fractional micro-lens array vs. ablative fractional 2940-nm Er:YAG laser for the treatment of atrophic acne scar in Asians: a 20-week prospective, randomized, split-face, controlled pilot study. Front Med (Lausanne). 2023 Nov 16;10:1248831. doi: 10.3389/fmed.2023.1248831. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Dai Ru, Ph.D principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpiece and a ablative fractional 2940-nm Er:YAG laser in people with Acne and Atrophic Scar, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 8 Feb 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 China. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of scar improvement evaluated by investigators (time frame: 8 weeks after final treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05686603, which also lists 1 linked publication.
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 8 Feb 2023.