Striae DistensaeNCT03390439
Treatment of Atrofic Striae With Percutaneous Collagen Induction Therapy Versus Fractional Nonablative Laser
A study testing Nd-Yap 1340nm laser and Microneedling in people with Striae Distensae, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
As atrophic striae are common dermatological conditions. Various therapeutic modalities have been employed in the treatment of striae distensae, mainly in striae rubra. There are few studies that include the treatment of striae alba. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Striae Distensae
- What is being tested?
- Nd-Yap 1340nm laser and Microneedling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2017to 20 Apr 2018
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients,
- age 18 and over;
- presenting with abdominal striae rubra diagnosed after clinical examination;
- patients with weight stability in the last four months;
- patients with Fitzpatrick III or IV phototype.
Who cannot join
- pregnant women;
- childbirth for less than 12 months;
- history of keloid scars;
- presence of localized or systemic infection;
- presence of immunosuppression;
- use of photosensitizing medications;
Show all 12Show fewer
- use of systemic steroids;
- use of oral isotretinoin in the last 12 months;
- history of diseases of collagen or elastic fibers;
- hypersensitivity to infiltrative or topical anesthetics;
- patients who have been treated for striae distensae in the last year;
- presence of sun exposure during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Atrofic Striae With Percutaneous Collagen Induction Therapy Versus Fractional Nonablative Laser: a Randomized Trial
As atrophic striae are common dermatological conditions. Various therapeutic modalities have been employed in the treatment of striae distensae, mainly in striae rubra. There are few studies that include the treatment of striae alba.
The non-ablative fractionated laser and, more recently, microneedling are two distinct treatments, but they are widely used in dermatologist practice.
The present randomized clinical trial is aimed at evaluating and evaluating the response of microneedle and fractional non-ablative laser Nd-yap 1340 in the treatment of abdominal striae alba.
Read the detailed description
Twenty patients will be treated at the dermatologic clinic of the Hospital de Clínicas de Porto Alegre (HCPA). Each patient will be treated with laser and microneedle at the same time, being applied a therapeutic procedure in each part of the abdomen (divided lengthwise and in equal parts). Each part of the abdomen will be randomized for the treatment of laser or microneedling with the help of the Excel 2013 program. The investigator responsible for procedures and patients are the only ones with unblinded assessment in relation to the side of each treatment. There will be 5 sessions with monthly intervals of the proposed treatments. The ND-yap 1340-nm laser will be used, and in the other segment of the abdomen, the dermaroller 2.5 mm was applied. Photographic records of patients will be performed at pre-treatment and 1 month after the third and fifth sessions. The questionnaires will be applied to assess the quality of life in dermatology DLQI (Dermatology Life Quality Index). Two independent and blind evaluators for the type of treatment will apply in the Global Aesthetic Scale (GAIS) in the evaluation of photographic records. Cutaneous biopsies for histopathological evaluation will be performed with a punch 3 mm of each part of the abdomen at pretreatment. Two experienced pathologists will evaluate the measurements of the epidermis and the collagen and elastic fibers of the skin.
- Conditions
- Striae Distensae
- Being tested
- Nd-Yap 1340nm laser, Microneedling
- Keywords
- Striae alba, Microneedling, Fractional nonablative laser, dermaroller, Nd-yap 1340nm laser, Percutaneous Collagen Induction Therapy
- Medical subject headings
- Striae Distensae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nd-Yap 1340nm laserDevice
Also called Nonablative Fractional Laser
Each part of the abdomen will be treated with a therapeutic modality. The ND-yap 1340-nm laser will be used in the following parameters: 90 mtz / cm2 nozzle, 90 mJ / mtz power, 2.5 Hz frequency, 3 ms pulse duration, 1 pass.
MicroneedlingDevice
Also called Dermaroller, Percutaneous Collagen Induction Therapy
In the other segment of the abdomen, the dermaroller 2.5 mm will be applied, with ten to fifteen passes in the same direction and at least four crosses in the rolling areas.
| Study group | Role | What they receive |
|---|---|---|
| Nd-Yap 1340nm laser | Active comparator | The randomly assigned segment of the abdomen will receive 5 sessions with monthly intervals of Nd-yap 1340nm laser. Receives: Device: Nd-Yap 1340nm laser |
| Microneedling | Experimental | The randomly assigned segment of the abdomen will receive 5 sessions with monthly intervals of dermaroller 2,5mm. Receives: Device: Microneedling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response in abdominal alba striae after the therapies
Clinical response to microneedle treatment and nonablative fractional laser treatment without abdominal alba striae (GAIS scale). The GAIS scale is a non-numerical scale divided into 5 categories of clinical response: very much improved, much improved, improved, no changed and worse.
Measured: 6 months
Secondary outcomes (11)
Clinical response to microneedle treatment and nonablative fractional laser treatment
Clinical response to microneedle treatment and nonablative fractional laser treatment without abdominal alba striae (GAIS scale). The GAIS scale is a non-numerical scale divided into 5 categories of clinical response: very much improved, much improved, improved, not changed and worse.
Measured: 4 months
Histopatological response in abdominal striae alba after the therapies
Histopathological evaluation of the thickness of the epidermis, as collagen and elastic (picrosirius stain, orcein stain)
Measured: 4 months
Histopatological response in abdominal striae alba after the therapies
Histopathological evaluation of the thickness of the epidermis, as collagen and elastic (picrosirius stain, orcein stain)
Measured: 6 months
The tolerability and incidence of adverse effects during the therapies
To assess the tolerability and the incidence of immediate and late adverse effects (pain, skin erythema, pruritus) for both techniques
Measured: 1 month
The tolerability and incidence of adverse effects during the therapies
To assess the tolerability and the incidence of immediate and late adverse effects (pain, skin erythema, pruritus) for both techniques
Measured: 2 months
The tolerability and incidence of adverse effects during the therapies
To assess the tolerability and the incidence of immediate and late adverse effects (pain, skin erythema, pruritus) for both techniques
Measured: 3 months
The tolerability and incidence of adverse effects during the therapies
To assess the tolerability and the incidence of immediate and late adverse effects (pain, skin erythema, pruritus) for both techniques
Measured: 4 months
The tolerability and incidence of adverse effects during the therapies
To assess the tolerability and the incidence of immediate and late adverse effects (pain, skin erythema, pruritus) for both techniques
Measured: 5 months
The impact on the quality of life provided by the striae distensae
To evaluate the impact on the quality of life (DLQI) provided by the striae. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions.The DLQI is the most frequently used instrument in studies of randomised controlled trials in dermatology.
The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
0-1: no effect at all on patient's life 2-5: small effect on patient's life 6-10: moderate effect on patient's life 11-20: very large effect on patient's life 21-30:extremely large effect on patient's life
Measured: Pre-treatment (first day of the evaluation)
The impact on the quality of life provided by the striae distensae
To evaluate the impact on the quality of life (DLQI) provided by the striae. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions.The DLQI is the most frequently used instrument in studies of randomised controlled trials in dermatology.
The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
0-1: no effect at all on patient's life 2-5: small effect on patient's life 6-10: moderate effect on patient's life 11-20: very large effect on patient's life 21-30:extremely large effect on patient's life.
Measured: 4 months
The impact on the quality of life provided by the striae distensae
To evaluate the impact on the quality of life (DLQI) provided by the striae. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions.The DLQI is the most frequently used instrument in studies of randomised controlled trials in dermatology.
The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
0-1: no effect at all on patient's life 2-5: small effect on patient's life 6-10: moderate effect on patient's life 11-20: very large effect on patient's life 21-30:extremely large effect on patient's life.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start1 Jul 2017
- Primary completion10 Apr 2018
- Study completion20 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Striae DistensaeStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Parallel groups
- Model description
- Each patient will have the abdomen divided equally. Each segment of the abdomen will be randomized using the Excel 2013 program to receive laser or microneedle treatment.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Associação Fundo de Incentivo à Pesquisa, MTO Importadora e Distribuidora, Vydence Medical, Aché Laboratórios Farmacêuticos Ltda
- Responsible party
- Sponsor
- Investigators
- Tania F Cestari, Dr, Study director, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390439
- Sponsor's protocol ID
- 47639415.1.0000.5327
- Status last verified
- Jun 2017
- First submitted
- 27 Dec 2017
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al-Himdani S, Ud-Din S, Gilmore S, Bayat A. Striae distensae: a comprehensive review and evidence-based evaluation of prophylaxis and treatment. Br J Dermatol. 2014 Mar;170(3):527-47. doi: 10.1111/bjd.12681.
PubMed 24125059Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.
PubMed 15216537Yang YJ, Lee GY. Treatment of Striae Distensae with Nonablative Fractional Laser versus Ablative CO(2) Fractional Laser: A Randomized Controlled Trial. Ann Dermatol. 2011 Nov;23(4):481-9. doi: 10.5021/ad.2011.23.4.481. Epub 2011 Nov 3.
PubMed 22148016Geronemus RG. Fractional photothermolysis: current and future applications. Lasers Surg Med. 2006 Mar;38(3):169-76. doi: 10.1002/lsm.20310.
PubMed 16532440de Angelis F, Kolesnikova L, Renato F, Liguori G. Fractional nonablative 1540-nm laser treatment of striae distensae in Fitzpatrick skin types II to IV: clinical and histological results. Aesthet Surg J. 2011 May;31(4):411-9. doi: 10.1177/1090820X11402493.
PubMed 21551432Cachafeiro T, Escobar G, Maldonado G, Cestari T, Corleta O. Comparison of Nonablative Fractional Erbium Laser 1,340 nm and Microneedling for the Treatment of Atrophic Acne Scars: A Randomized Clinical Trial. Dermatol Surg. 2016 Feb;42(2):232-41. doi: 10.1097/DSS.0000000000000597.
PubMed 26845539Park KY, Kim HK, Kim SE, Kim BJ, Kim MN. Treatment of striae distensae using needling therapy: a pilot study. Dermatol Surg. 2012 Nov;38(11):1823-8. doi: 10.1111/j.1524-4725.2012.02552.x. Epub 2012 Aug 22.
PubMed 22913429Hexsel D, Soirefmann M, Porto MD, Schilling-Souza J, Siega C, Dal'Forno T. Superficial dermabrasion versus topical tretinoin on early striae distensae: a randomized, pilot study. Dermatol Surg. 2014 May;40(5):537-44. doi: 10.1111/dsu.12460. Epub 2014 Feb 26.
PubMed 24612027Zeitter S, Sikora Z, Jahn S, Stahl F, Strauss S, Lazaridis A, Reimers K, Vogt PM, Aust MC. Microneedling: matching the results of medical needling and repetitive treatments to maximize potential for skin regeneration. Burns. 2014 Aug;40(5):966-73. doi: 10.1016/j.burns.2013.12.008. Epub 2014 Feb 7.
PubMed 24513133Aust MC, Fernandes D, Kolokythas P, Kaplan HM, Vogt PM. Percutaneous collagen induction therapy: an alternative treatment for scars, wrinkles, and skin laxity. Plast Reconstr Surg. 2008 Apr;121(4):1421-1429. doi: 10.1097/01.prs.0000304612.72899.02.
PubMed 18349665Naspolini AP, Boza JC, da Silva VD, Cestari TF. Efficacy of Microneedling Versus Fractional Non-ablative Laser to Treat Striae Alba: A Randomized Study. Am J Clin Dermatol. 2019 Apr;20(2):277-287. doi: 10.1007/s40257-018-0415-0.
PubMed 30618025
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Atrofic Striae With Percutaneous Collagen Induction Therapy Versus Fractional Nonablative Laser: a Randomized Trial
- ClinicalTrials.gov ID
- NCT03390439
- Acronym / sponsor ID
- 47639415.1.0000.5327
- Conditions
- Striae Distensae
- Keywords
- Striae alba, Microneedling, Fractional nonablative laser, dermaroller, Nd-yap 1340nm laser, Percutaneous Collagen Induction Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Associação Fundo de Incentivo à Pesquisa, MTO Importadora e Distribuidora, Vydence Medical, Aché Laboratórios Farmacêuticos Ltda
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 4 Jan 2018 (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.
As atrophic striae are common dermatological conditions. Various therapeutic modalities have been employed in the treatment of striae distensae, mainly in striae rubra. There are few studies that include the treatment of striae alba.
The non-ablative fractionated laser and, more recently, microneedling are two distinct treatments, but they are widely used in dermatologist practice.
The present randomized clinical trial is aimed at evaluating and evaluating the response of microneedle and fractional non-ablative laser Nd-yap 1340 in the treatment of abdominal striae alba.
Detailed description
Twenty patients will be treated at the dermatologic clinic of the Hospital de Clínicas de Porto Alegre (HCPA). Each patient will be treated with laser and microneedle at the same time, being applied a therapeutic procedure in each part of the abdomen (divided lengthwise and in equal parts). Each part of the abdomen will be randomized for the treatment of laser or microneedling with the help of the Excel 2013 program. The investigator responsible for procedures and patients are the only ones with unblinded assessment in relation to the side of each treatment. There will be 5 sessions with monthly intervals of the proposed treatments. The ND-yap 1340-nm laser will be used, and in the other segment of the abdomen, the dermaroller 2.5 mm was applied. Photographic records of patients will be performed at pre-treatment and 1 month after the third and fifth sessions. The questionnaires will be applied to assess the quality of life in dermatology DLQI (Dermatology Life Quality Index). Two independent and blind evaluators for the type of treatment will apply in the Global Aesthetic Scale (GAIS) in the evaluation of photographic records. Cutaneous biopsies for histopathological evaluation will be performed with a punch 3 mm of each part of the abdomen at pretreatment. Two experienced pathologists will evaluate the measurements of the epidermis and the collagen and elastic fibers of the skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Each patient will have the abdomen divided equally. Each segment of the abdomen will be randomized using the Excel 2013 program to receive laser or microneedle treatment.
| Arm | Type | Receives |
|---|---|---|
| Nd-Yap 1340nm laser | Active comparator | Device: Nd-Yap 1340nm laserThe randomly assigned segment of the abdomen will receive 5 sessions with monthly intervals of Nd-yap 1340nm laser. |
| Microneedling | Experimental | Device: MicroneedlingThe randomly assigned segment of the abdomen will receive 5 sessions with monthly intervals of dermaroller 2,5mm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- female patients,
- age 18 and over;
- presenting with abdominal striae rubra diagnosed after clinical examination;
- patients with weight stability in the last four months;
- patients with Fitzpatrick III or IV phototype.
Key exclusion criteria (12 listed)
- pregnant women;
- childbirth for less than 12 months;
- history of keloid scars;
- presence of localized or systemic infection;
- presence of immunosuppression;
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 |
|---|---|---|
| Nd-Yap 1340nm laserAlso: Nonablative Fractional LaserEach part of the abdomen will be treated with a therapeutic modality. The ND-yap 1340-nm laser will be used in the following parameters: 90 mtz / cm2 nozzle, 90 mJ / mtz power, 2.5 Hz frequency, 3 ms pulse duration, 1 pass. | Device | Nd-Yap 1340nm laser |
| MicroneedlingAlso: Dermaroller, Percutaneous Collagen Induction TherapyIn the other segment of the abdomen, the dermaroller 2.5 mm will be applied, with ten to fifteen passes in the same direction and at least four crosses in the rolling areas. | Device | Microneedling |
Primary outcome
Clinical response in abdominal alba striae after the therapies
Time frame: 6 months
Clinical response to microneedle treatment and nonablative fractional laser treatment without abdominal alba striae (GAIS scale). The GAIS scale is a non-numerical scale divided into 5 categories of clinical response: very much improved, much improved, improved, no changed and worse.
11 secondary outcomes
Clinical response to microneedle treatment and nonablative fractional laser treatment
Time frame: 4 months
Histopatological response in abdominal striae alba after the therapies
Time frame: 4 months
Histopatological response in abdominal striae alba after the therapies
Time frame: 6 months
The tolerability and incidence of adverse effects during the therapies
Time frame: 1 month
The tolerability and incidence of adverse effects during the therapies
Time frame: 2 months
The tolerability and incidence of adverse effects during the therapies
Time frame: 3 months
The tolerability and incidence of adverse effects during the therapies
Time frame: 4 months
The tolerability and incidence of adverse effects during the therapies
Time frame: 5 months
The impact on the quality of life provided by the striae distensae
Time frame: Pre-treatment (first day of the evaluation)
The impact on the quality of life provided by the striae distensae
Time frame: 4 months
The impact on the quality of life provided by the striae distensae
Time frame: 6 months
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 1 Aug 2018.
- Background: PubMed 24125059Al-Himdani S, Ud-Din S, Gilmore S, Bayat A. Striae distensae: a comprehensive review and evidence-based evaluation of prophylaxis and treatment. Br J Dermatol. 2014 Mar;170(3):527-47. doi: 10.1111/bjd.12681.
- Background: PubMed 15216537Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.
- Background: PubMed 22148016Yang YJ, Lee GY. Treatment of Striae Distensae with Nonablative Fractional Laser versus Ablative CO(2) Fractional Laser: A Randomized Controlled Trial. Ann Dermatol. 2011 Nov;23(4):481-9. doi: 10.5021/ad.2011.23.4.481. Epub 2011 Nov 3.
- Background: PubMed 16532440Geronemus RG. Fractional photothermolysis: current and future applications. Lasers Surg Med. 2006 Mar;38(3):169-76. doi: 10.1002/lsm.20310.
- Background: PubMed 21551432de Angelis F, Kolesnikova L, Renato F, Liguori G. Fractional nonablative 1540-nm laser treatment of striae distensae in Fitzpatrick skin types II to IV: clinical and histological results. Aesthet Surg J. 2011 May;31(4):411-9. doi: 10.1177/1090820X11402493.
- Background: PubMed 26845539Cachafeiro T, Escobar G, Maldonado G, Cestari T, Corleta O. Comparison of Nonablative Fractional Erbium Laser 1,340 nm and Microneedling for the Treatment of Atrophic Acne Scars: A Randomized Clinical Trial. Dermatol Surg. 2016 Feb;42(2):232-41. doi: 10.1097/DSS.0000000000000597.
- Background: PubMed 22913429Park KY, Kim HK, Kim SE, Kim BJ, Kim MN. Treatment of striae distensae using needling therapy: a pilot study. Dermatol Surg. 2012 Nov;38(11):1823-8. doi: 10.1111/j.1524-4725.2012.02552.x. Epub 2012 Aug 22.
- Background: PubMed 24612027Hexsel D, Soirefmann M, Porto MD, Schilling-Souza J, Siega C, Dal'Forno T. Superficial dermabrasion versus topical tretinoin on early striae distensae: a randomized, pilot study. Dermatol Surg. 2014 May;40(5):537-44. doi: 10.1111/dsu.12460. Epub 2014 Feb 26.
- Background: PubMed 24513133Zeitter S, Sikora Z, Jahn S, Stahl F, Strauss S, Lazaridis A, Reimers K, Vogt PM, Aust MC. Microneedling: matching the results of medical needling and repetitive treatments to maximize potential for skin regeneration. Burns. 2014 Aug;40(5):966-73. doi: 10.1016/j.burns.2013.12.008. Epub 2014 Feb 7.
- Background: PubMed 18349665Aust MC, Fernandes D, Kolokythas P, Kaplan HM, Vogt PM. Percutaneous collagen induction therapy: an alternative treatment for scars, wrinkles, and skin laxity. Plast Reconstr Surg. 2008 Apr;121(4):1421-1429. doi: 10.1097/01.prs.0000304612.72899.02.
- Derived from this study: PubMed 30618025Naspolini AP, Boza JC, da Silva VD, Cestari TF. Efficacy of Microneedling Versus Fractional Non-ablative Laser to Treat Striae Alba: A Randomized Study. Am J Clin Dermatol. 2019 Apr;20(2):277-287. doi: 10.1007/s40257-018-0415-0.
- Individual participant dataSharing planned: Undecided
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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.
Tania F Cestari, Dr study director
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 Nd-Yap 1340nm laser and Microneedling in people with Striae Distensae, run by Hospital de Clinicas de Porto Alegre 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 5 inclusion and 12 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 1 Aug 2018. 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?
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?
Clinical response in abdominal alba striae after the therapies (time frame: 6 months). 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 NCT03390439, which also lists 11 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 1 Aug 2018.