AcneNCT02025088
Comparison of Treatments for Atrophic Acne Scars
A study testing Laser and Microneedling in people with Acne and Scar, run by Thaís Hofmann Cachafeiro at 1 site in Brazil.
Trial summary
Acne scars have high prevalence, significant impact on quality of life and are a therapeutic challenge for dermatologists. Previous studies have shown promising results for the treatment of acne scars with non-ablative fractional laser and microneedling, however there are no studies comparing the these techniques. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Laser and Microneedling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2013to Nov 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of moderate or severe atrophic acne scars on the face
Who cannot join
- Previous history of photosensitivity or photosensitive diseases such as systemic lupus erythematosus or xeroderma pigmentosum
- Previous history or presence of post inflammatory hyperpigmentation
- Use of drugs that may induce hyperpigmentation, such as: amiodarone, clofazimine, minocycline or chloroquine
- Presence of only "ice pick" scars
- Pregnancy or lactation
- Use of oral isotretinoin in the last six months
Show all 14Show fewer
- History of facial treatments with laser or surgery in the last three months
- Herpetic infection, warts or any other active infection of the adjacent skin
- Presence of skin cancer or actinic keratoses
- Coagulopathies or anticoagulating therapy
- Previous history or presence of hypertrophic scars or keloids
- Patients being treated with chemotherapy, radiotherapy or corticosteroids at high doses
- Diabetes mellitus
- Inability to understand the goals and risks of treatment
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Thais H Cachafeiro, MD, 55 51 3359-8571, thaishofmann@gmail.com
Gabriela F Escobar, MD, 55 51 3359-8571, gabrieladermatologia@yahoo.com
About this study
Official title: Comparison of Non-ablative Fractional Erbium Laser 1340nm and Microneedling for the Treatment of Atrophic Acne Scars: a Randomized Clinical Trial.
Acne scars have high prevalence, significant impact on quality of life and are a therapeutic challenge for dermatologists. Previous studies have shown promising results for the treatment of acne scars with non-ablative fractional laser and microneedling, however there are no studies comparing the these techniques. Therefore, the objective of this study is to compare the effectiveness of treatment of atrophic acne scars on the face with non-ablative fractional erbium laser and microneedling.
Read the detailed description
Acne is a multifactorial inflammatory dermatosis of the pilosebaceous unit, affecting up to 80 percent of teenagers and approximately 20 percent of adults. Scaring can occur early in acne development and may affect up to 95% of patients with this disease. However, the prevalence of acne scarring varies depending on the study.
Acne scars causes impairment of quality of life and has been described as a risk factor for suicide. Furthermore, it has also been linked to poor self esteem, depression, anxiety and lowered academic performance.
The most common type of acne scarring is atrophic, which includes: ice pick, rolling scars and boxcar scars.
Many treatments have been used for atrophic scars, including resurfacing procedures (chemical peels, dermabrasion and laser treatments), excisional procedures (punch excision, elevation by punch and elliptical excision of scars), application of fillers and microneedling, the latter since 2005, with satisfactory results and minimum time recovery.
Previous studies have shown promising results for the treatment of acne scars with non-ablative fractional laser and microneedling. Previous reports have also shown that the latter is associated with rapid healing period, a low complication rate and a low risk of post inflammatory hyperpigmentation.
However, there are no studies comparing the efficacy of microneedling with other techniques of resurfacing.
This study will be a single-blinded randomized clinical trial, comparing the application of non-ablative fractional erbium laser ProDeep 1340 nm and the technique of induction of neocollagenesis by microneedling. The primary objective of this study is to compare the effectiveness of treatment of atrophic acne scars on the face with non-ablative fractional erbium laser and microneedling. The secondary objectives are: assess the degree of satisfaction of participants with both techniques; check tolerability and incidence of adverse effects with both techniques; assess time needed for recovery and number of days absent from work or social activities after the procedures and evaluate the opinion and physical discomfort of each technique.
For each participant, a questionnaire will be filled out with the following information: gender, age, skin type, profession, current or previous history of smoking, use of medications, and presence of active acne. To assess the degree of scarring of the participants, the scale "Quantitative Global Scarring Grading System for Postacne Scarring" will be applied. After this evaluation, patients will be randomly allocated in each study groups (simple randomization). The randomization system was performed with the Microsoft Excel randomization program. Patients in both groups will undergo three sessions of laser treatment or three treatment sessions with microneedling, with an interval of six weeks between them.
Two independent dermatologists, blinded to the group of treatment which each patient belongs to, will apply the Quantitative Global Grading System for Postacne Scarring before treatment, two months and six months after treatment. There are no clinical signs or characteristics that enable the evaluators to identify which group each patient is allocated and patients will be instructed to not provide this information. Six months after completion of treatment, patients will answer a questionnaire to assess their perceptions of the degree of improvement of their scars, pain during treatment and recovery time, assigning values from 0 to 10, where 0 means maximum dissatisfaction and 10, maximum satisfaction.
To detect a difference of one standard deviation in the range between the groups (laser and microneedling), with a power of 90% and an α error ≤ 0.05, 23 patients are required for each group. Data will be inserted in Excel and then exported to SPSS v18.0 for statistical analysis. Quantitative variables will be analyzed by mean and standard deviation and the groups will be compared by Student's t test for independent samples. To compare the variation of the measurements between the groups throughout the sessions the analysis of variance for repeated measures will be used. For the analysis of interobserver agreement the intraclass correlation coefficient and the Bland - Altman method will be used.
This project was approved by the Committee of Research Ethics of our Hospital and all participants will sign an informed consent.
- Being tested
- Laser, Microneedling
- Medical subject headings
- Acne Vulgaris, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserProcedure or surgery
Also called Non-ablative fractional erbium laser 1340 nm ProDeep
Patients of this arm will undergo three sessions of laser treatment with an interval of six weeks between them. In each laser session, the non-ablative fractional erbium laser 1340 nm ProDeep (Etheria ® platform/Industra) with tip 100mtz/cm ² will be applied across the face, with a power of 120mJ/mtz time and pulse time of 5ms.
MicroneedlingProcedure or surgery
Also called Dermaroller
Patients in this arm will undergo three sessions with microneedling, with an interval of six weeks between them. In the microneedling sessions, the instrument contains 192 microneedles with 2 mm depth, which will be applied to the face in four different directions, making up about 20 movements of "coming and going" in each direction.
| Study group | Role | What they receive |
|---|---|---|
| Laser | Active comparator | In each laser session, the non-ablative fractional erbium laser 1340 nm ProDeep (Etheria ® platform/Industra) with tip 100mtz/cm ² will be applied across the face, with a power of 120mJ/mtz time and pulse time of 5ms. Receives: Procedure: Laser |
| Microneedling | Active comparator | In the microneedling sessions, the instrument contains 192 microneedles with 2 mm depth, which will be applied to the face in four different directions, making up about 20 movements of "coming and going" in each direction. Receives: Procedure: Microneedling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Global Grading System for Postacne Scarring
Goodman et al. in 2006, developed a scale of global severity of acne scarring, known as the Quantitative Global Scarring Grading System for Postacne Scarring. It relies on a scar count by type, calculating a score according to the number and severity of each type. The grading limits of this instrument are between 0-84 points and it seems to be an accurate and reproducible tool.
Measured: Before treatment, two months and six months after treatment
Secondary outcomes (2)
Questionnaire to assess patients perceptions of the degree of improvement of scars with the treatment
Measured: Six months after treatment
Questionnaire to assess patients pain during treatment and recovery time
Measured: Six months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionAug 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AcneStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thaís Hofmann Cachafeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thaís Hofmann Cachafeiro, Hospital de Clinicas de Porto Alegre
- Investigators
- Thais H Cachafeiro, MD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025088
- Sponsor's protocol ID
- THC 13/14
- Status last verified
- Dec 2013
- First submitted
- 29 Dec 2013
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Goodman GJ. Postacne scarring: a review of its pathophysiology and treatment. Dermatol Surg. 2000 Sep;26(9):857-71. doi: 10.1046/j.1524-4725.2000.99232.x.
PubMed 10971560Grevelink JM, White VR. Concurrent use of laser skin resurfacing and punch excision in the treatment of facial acne scarring. Dermatol Surg. 1998 May;24(5):527-30. doi: 10.1111/j.1524-4725.1998.tb04201.x.
PubMed 9598006Hu S, Hsiao WC, Chen MC, Huang YL, Chang SL, Shih PY, Gold MH. Ablative fractional erbium-doped yttrium aluminum garnet laser with coagulation mode for the treatment of atrophic acne scars in Asian skin. Dermatol Surg. 2011 Jul;37(7):939-44. doi: 10.1111/j.1524-4725.2011.02009.x. Epub 2011 May 25.
PubMed 21615599Fernandes D. Minimally invasive percutaneous collagen induction. Oral Maxillofac Surg Clin North Am. 2005 Feb;17(1):51-63, vi. doi: 10.1016/j.coms.2004.09.004.
PubMed 18088764Fife D. Practical evaluation and management of atrophic acne scars: tips for the general dermatologist. J Clin Aesthet Dermatol. 2011 Aug;4(8):50-7.
PubMed 21909457Fabbrocini G, Annunziata MC, D'Arco V, De Vita V, Lodi G, Mauriello MC, Pastore F, Monfrecola G. Acne scars: pathogenesis, classification and treatment. Dermatol Res Pract. 2010;2010:893080. doi: 10.1155/2010/893080. Epub 2010 Oct 14.
PubMed 20981308Sobanko JF, Alster TS. Management of acne scarring, part I: a comparative review of laser surgical approaches. Am J Clin Dermatol. 2012 Oct 1;13(5):319-30. doi: 10.2165/11598910-000000000-00000.
PubMed 22612738Sardana K, Garg VK, Arora P, Khurana N. Histological validity and clinical evidence for use of fractional lasers for acne scars. J Cutan Aesthet Surg. 2012 Apr;5(2):75-90. doi: 10.4103/0974-2077.99431.
PubMed 23060702Majid I. Microneedling therapy in atrophic facial scars: an objective assessment. J Cutan Aesthet Surg. 2009 Jan;2(1):26-30. doi: 10.4103/0974-2077.53096.
PubMed 20300368Goodman GJ, Baron JA. Postacne scarring--a quantitative global scarring grading system. J Cosmet Dermatol. 2006 Mar;5(1):48-52. doi: 10.1111/j.1473-2165.2006.00222.x.
PubMed 17173571
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Non-ablative Fractional Erbium Laser 1340nm and Microneedling for the Treatment of Atrophic Acne Scars: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02025088
- Acronym / sponsor ID
- THC 13/14
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Thaís Hofmann CachafeiroUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 31 Dec 2013 (estimated)
- 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.
Acne scars have high prevalence, significant impact on quality of life and are a therapeutic challenge for dermatologists. Previous studies have shown promising results for the treatment of acne scars with non-ablative fractional laser and microneedling, however there are no studies comparing the these techniques. Therefore, the objective of this study is to compare the effectiveness of treatment of atrophic acne scars on the face with non-ablative fractional erbium laser and microneedling.
Detailed description
Acne is a multifactorial inflammatory dermatosis of the pilosebaceous unit, affecting up to 80 percent of teenagers and approximately 20 percent of adults. Scaring can occur early in acne development and may affect up to 95% of patients with this disease. However, the prevalence of acne scarring varies depending on the study.
Acne scars causes impairment of quality of life and has been described as a risk factor for suicide. Furthermore, it has also been linked to poor self esteem, depression, anxiety and lowered academic performance.
The most common type of acne scarring is atrophic, which includes: ice pick, rolling scars and boxcar scars.
Many treatments have been used for atrophic scars, including resurfacing procedures (chemical peels, dermabrasion and laser treatments), excisional procedures (punch excision, elevation by punch and elliptical excision of scars), application of fillers and microneedling, the latter since 2005, with satisfactory results and minimum time recovery.
Previous studies have shown promising results for the treatment of acne scars with non-ablative fractional laser and microneedling. Previous reports have also shown that the latter is associated with rapid healing period, a low complication rate and a low risk of post inflammatory hyperpigmentation.
However, there are no studies comparing the efficacy of microneedling with other techniques of resurfacing.
This study will be a single-blinded randomized clinical trial, comparing the application of non-ablative fractional erbium laser ProDeep 1340 nm and the technique of induction of neocollagenesis by microneedling. The primary objective of this study is to compare the effectiveness of treatment of atrophic acne scars on the face with non-ablative fractional erbium laser and microneedling. The secondary objectives are: assess the degree of satisfaction of participants with both techniques; check tolerability and incidence of adverse effects with both techniques; assess time needed for recovery and number of days absent from work or social activities after the procedures and evaluate the opinion and physical discomfort of each technique.
For each participant, a questionnaire will be filled out with the following information: gender, age, skin type, profession, current or previous history of smoking, use of medications, and presence of active acne. To assess the degree of scarring of the participants, the scale "Quantitative Global Scarring Grading System for Postacne Scarring" will be applied. After this evaluation, patients will be randomly allocated in each study groups (simple randomization). The randomization system was performed with the Microsoft Excel randomization program. Patients in both groups will undergo three sessions of laser treatment or three treatment sessions with microneedling, with an interval of six weeks between them.
Two independent dermatologists, blinded to the group of treatment which each patient belongs to, will apply the Quantitative Global Grading System for Postacne Scarring before treatment, two months and six months after treatment. There are no clinical signs or characteristics that enable the evaluators to identify which group each patient is allocated and patients will be instructed to not provide this information. Six months after completion of treatment, patients will answer a questionnaire to assess their perceptions of the degree of improvement of their scars, pain during treatment and recovery time, assigning values from 0 to 10, where 0 means maximum dissatisfaction and 10, maximum satisfaction.
To detect a difference of one standard deviation in the range between the groups (laser and microneedling), with a power of 90% and an α error ≤ 0.05, 23 patients are required for each group. Data will be inserted in Excel and then exported to SPSS v18.0 for statistical analysis. Quantitative variables will be analyzed by mean and standard deviation and the groups will be compared by Student's t test for independent samples. To compare the variation of the measurements between the groups throughout the sessions the analysis of variance for repeated measures will be used. For the analysis of interobserver agreement the intraclass correlation coefficient and the Bland - Altman method will be used.
This project was approved by the Committee of Research Ethics of our Hospital and all participants will sign an informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser | Active comparator | Procedure: LaserIn each laser session, the non-ablative fractional erbium laser 1340 nm ProDeep (Etheria ® platform/Industra) with tip 100mtz/cm ² will be applied across the face, with a power of 120mJ/mtz time and pulse time of 5ms. |
| Microneedling | Active comparator | Procedure: MicroneedlingIn the microneedling sessions, the instrument contains 192 microneedles with 2 mm depth, which will be applied to the face in four different directions, making up about 20 movements of "coming and going" in each direction. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of moderate or severe atrophic acne scars on the face
Key exclusion criteria (14 listed)
- Previous history of photosensitivity or photosensitive diseases such as systemic lupus erythematosus or xeroderma pigmentosum
- Previous history or presence of post inflammatory hyperpigmentation
- Use of drugs that may induce hyperpigmentation, such as: amiodarone, clofazimine, minocycline or chloroquine
- Presence of only "ice pick" scars
- Pregnancy or lactation
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 |
|---|---|---|
| LaserAlso: Non-ablative fractional erbium laser 1340 nm ProDeepPatients of this arm will undergo three sessions of laser treatment with an interval of six weeks between them. In each laser session, the non-ablative fractional erbium laser 1340 nm ProDeep (Etheria ® platform/Industra) with tip 100mtz/cm ² will be applied across the face, with a power of 120mJ/mtz time and pulse time of 5ms. | Procedure or surgery | Laser |
| MicroneedlingAlso: DermarollerPatients in this arm will undergo three sessions with microneedling, with an interval of six weeks between them. In the microneedling sessions, the instrument contains 192 microneedles with 2 mm depth, which will be applied to the face in four different directions, making up about 20 movements of "coming and going" in each direction. | Procedure or surgery | Microneedling |
Primary outcome
Quantitative Global Grading System for Postacne Scarring
Time frame: Before treatment, two months and six months after treatment
Goodman et al. in 2006, developed a scale of global severity of acne scarring, known as the Quantitative Global Scarring Grading System for Postacne Scarring. It relies on a scar count by type, calculating a score according to the number and severity of each type. The grading limits of this instrument are between 0-84 points and it seems to be an accurate and reproducible tool.
2 secondary outcomes
Questionnaire to assess patients perceptions of the degree of improvement of scars with the treatment
Time frame: Six months after treatment
Questionnaire to assess patients pain during treatment and recovery time
Time frame: Six months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2013.
- Background: PubMed 10971560Goodman GJ. Postacne scarring: a review of its pathophysiology and treatment. Dermatol Surg. 2000 Sep;26(9):857-71. doi: 10.1046/j.1524-4725.2000.99232.x.
- Background: PubMed 9598006Grevelink JM, White VR. Concurrent use of laser skin resurfacing and punch excision in the treatment of facial acne scarring. Dermatol Surg. 1998 May;24(5):527-30. doi: 10.1111/j.1524-4725.1998.tb04201.x.
- Background: PubMed 21615599Hu S, Hsiao WC, Chen MC, Huang YL, Chang SL, Shih PY, Gold MH. Ablative fractional erbium-doped yttrium aluminum garnet laser with coagulation mode for the treatment of atrophic acne scars in Asian skin. Dermatol Surg. 2011 Jul;37(7):939-44. doi: 10.1111/j.1524-4725.2011.02009.x. Epub 2011 May 25.
- Background: PubMed 18088764Fernandes D. Minimally invasive percutaneous collagen induction. Oral Maxillofac Surg Clin North Am. 2005 Feb;17(1):51-63, vi. doi: 10.1016/j.coms.2004.09.004.
- Background: PubMed 21909457Fife D. Practical evaluation and management of atrophic acne scars: tips for the general dermatologist. J Clin Aesthet Dermatol. 2011 Aug;4(8):50-7.
- Background: PubMed 20981308Fabbrocini G, Annunziata MC, D'Arco V, De Vita V, Lodi G, Mauriello MC, Pastore F, Monfrecola G. Acne scars: pathogenesis, classification and treatment. Dermatol Res Pract. 2010;2010:893080. doi: 10.1155/2010/893080. Epub 2010 Oct 14.
- Background: PubMed 22612738Sobanko JF, Alster TS. Management of acne scarring, part I: a comparative review of laser surgical approaches. Am J Clin Dermatol. 2012 Oct 1;13(5):319-30. doi: 10.2165/11598910-000000000-00000.
- Background: PubMed 23060702Sardana K, Garg VK, Arora P, Khurana N. Histological validity and clinical evidence for use of fractional lasers for acne scars. J Cutan Aesthet Surg. 2012 Apr;5(2):75-90. doi: 10.4103/0974-2077.99431.
- Background: PubMed 20300368Majid I. Microneedling therapy in atrophic facial scars: an objective assessment. J Cutan Aesthet Surg. 2009 Jan;2(1):26-30. doi: 10.4103/0974-2077.53096.
- Background: PubMed 17173571Goodman GJ, Baron JA. Postacne scarring--a quantitative global scarring grading system. J Cosmet Dermatol. 2006 Mar;5(1):48-52. doi: 10.1111/j.1473-2165.2006.00222.x.
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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.
Thais H Cachafeiro, MD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser and Microneedling in people with Acne and Scar, run by Thaís Hofmann Cachafeiro at 1 site in Brazil.
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 1 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 31 Dec 2013. 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 Brazil. 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 Thais H Cachafeiro, MD (55 51 3359-8571, thaishofmann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Global Grading System for Postacne Scarring (time frame: Before treatment, two months and six months after treatment). 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 NCT02025088, which also lists 10 linked publications.
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 31 Dec 2013.