Striae; AtrophyNCT06636799
MICRONEEDLING ON CLINICAL PARAMETERS OF STRIAE ALBA AND MORPHOLOGICAL PARAMETERS OF THE FEMALE TEGUMENTARY SYSTEM
A study testing Microneedling only and Microneedling and actives in people with Striae; Atrophy, run by Isabel de Almeida Paz at 1 site in Brazil.
Trial summary
Stretch marks are dermal scars of multifactorial etiology, for which several treatments have been proposed. Among these is microneedling (MN), a technique that stimulates collagen production. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Striae; Atrophy
- What is being tested?
- Microneedling only and Microneedling and actives
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jan 2024to 1 Sep 2024
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women (self-declaration of no diseases)
- Age between 18 and 35 years
- Presence of striae alba in the gluteal region
Who cannot join
- Health problems (cardiovascular, neurological, or musculoskeletal impairment)
- History of keloids
- Allergic disorders
- Skin cancer
- Systemic disease
- Diabetes mellitus
Show all 11Show fewer
- Pregnant women
- Lactating women
- Psoriasis sufferers
- Hypersensitivity
- Use of peels, lasers, or any similar treatment in the last three months or any contraindication for performing microneedling.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade do Vale do Rio dos Sinos
São Leopoldo, Rio Grande do Sul, 93.022-750
About this study
Official title: EFFECTS OF MICRONEEDLING ON CLINICAL PARAMETERS OF STRIAE ALBA AND MORPHOLOGICAL PARAMETERS OF THE FEMALE TEGUMENTARY SYSTEM: A RANDOMIZED CLINICAL TRIAL
Stretch marks are dermal scars of multifactorial etiology, for which several treatments have been proposed. Among these is microneedling (MN), a technique that stimulates collagen production. However, the effects of MA alone and in combination with active agents on the length and area of stretch marks and the thickness of the integumentary system are not well understood, as the literature is scarce. Therefore, the objectives of this study were: To assess the effects of MA alone and in combination with active agents (growth factors, hyaluronic acid, and Hydroxyprolisilane CN®️) on clinical parameters (area and length) of stretch marks and morphological parameters (dermal and hypodermal thickness) of the female integumentary system. The sample was randomized into a control group (G1) that did not receive treatment, G2 that received MN alone, and G3 that received MN combined with active agents. Groups G2 and G3 underwent 3 sessions of the protocol with a 4-week interval. Groups were evaluated at the beginning and 4 months after the start of the protocol. Evaluation of the area and length of stretch marks was performed through photography, dermal and hypodermal thickness was assessed via ultrasonography, and satisfaction levels were measured using the Likert scale.
Read the detailed description
This study was a randomized clinical trial in blocks with a 1:1 allocation, stratified by weight. The study was duly adapted to resolution 466/12 of the National Health Council on research involving human beings and to the Declaration of Helsinki. The evaluations and treatment protocols were carried out at the Physiotherapy Clinic of a Private Higher Education Institution.. The sample was characterized by convenience and healthy women who met the inclusion criteria were recruited, mainly via social networks. To calculate the sample size, the G-Power software (version 3.1.3; University of Trier, Trier, Germany) was used and the significance level adopted was α = 0.05 and power (1-β) = 0.80. No similar studies were found, so f 0.30 was used as the effect size. Therefore, the minimum number of participants required for the study was estimated at 24 participants. Considering possible losses during the protocol, 26 participants (+10%) were recruited. Randomization was performed by stratifying by weight. The randomization list was kept in opaque and sealed envelopes, ensuring that the allocation was hidden and random and that the therapist responsible for applying the microneedling had contact with the randomization only on the day of the protocol application. In the present study, the sample of 26 participants was divided into three groups. Group one (G1), control, composed of eight people, underwent all the evaluations, but did not receive the microneedling protocol or actives. Group two (G2), composed of nine people, underwent all the proposed evaluations and the isolated microneedling procedure. Group three (G3), composed of nine people, underwent all the proposed evaluations and the microneedling procedure associated with actives. Groups G2 and G3 underwent 3 sessions of the protocol with a 4-week interval. Groups were evaluated at the beginning and 4 months after the start of the protocol. Evaluation of the area and length of stretch marks was performed through photography, dermal and hypodermal thickness was assessed via ultrasonography, and satisfaction levels were measured using the Likert scale.This study adopted the intention-to-treat approach. Therefore, participants who did not attend the scheduled sessions were rescheduled, allowing all sessions planned to be carried out. When the decision was made to withdraw, the data collected up until the end were used for analysis.
- Conditions
- Striae; Atrophy
- Being tested
- Microneedling only, Microneedling and actives
- Medical subject headings
- Striae Distensae, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedling onlyDevice
In this procedure, a derma roller composed of 1.5 mm microneedles from the Smart Derma Roller brand with 540 titanium needles was used. The protocol was performed by passing the derma roller ten times in the following directions: horizontal, vertical, and diagonal right and left.
Microneedling and activesOther
In this procedure, a derma roller composed of 1.5 mm microneedles from the Smart Derma Roller brand with 540 titanium needles was used. The protocol was performed by passing the derma roller ten times in the following directions: horizontal, vertical, and diagonal right and left. Group G3 received microneedling associated with active ingredients. This manipulated active ingredient was composed of growth factors (EGF Factor, TGFß3 Factor, and IDP-2 Peptide), Hydroxyprolisilane, and hyaluronic acid.
| Study group | Role | What they receive |
|---|---|---|
| Microneedling only | Experimental | In this procedure, only the derma roller composed of 1.5 mm microneedles from the Smart Derma Roller brand with 540 titanium needles was used. Receives: Device: Microneedling only |
| Microneedling associated with actives | Active comparator | In this procedure, a derma roller composed of 1.5 mm microneedles from the Smart Derma Roller brand with 540 titanium needles associated with active ingredients were used. Receives: Other: Microneedling and actives |
| Control | No intervention | This group did not receive intervention but participated in pre- and post-protocol assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area of stretch marks
Photographic image analysis was performed before and after the protocol.These images will be analyzed later by tracing the area of the entire stria.
Measured: 30 minutes
The thickness of stretch marks
Photographic image analysis was performed before and after the protocol. These images will be analyzed later by drawing a line between the upper and lower edges of the stria.
Measured: 30 minutes
Secondary outcomes (3)
Skin thickness
Ultrasound images collected before the first session and 30 days after the last session were analyzed. These images will be examined later, and the thickness of the skin will be evaluated.
Measured: 30 minutes
Likert scale of patient satisfaction
A questionnaire was used to assess the level of satisfaction through non-standardized questions. Therefore, for adequate evaluation, in this study, patients undergoing microneedling post-treatment were asked about their level of satisfaction with the color, length and width of stretch marks, final skin quality, time of treatment and quality of care.
Measured: 20 minutes
Hypodermis thickness
Ultrasound images collected before the first session and 30 days after the last session were analyzed. These images will be examined later, and the thickness of the hypodermis will be evaluated.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start20 Jan 2024
- Primary completion20 Jul 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Striae; AtrophyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isabel de Almeida Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Isabel de Almeida Paz, University of the Sinos Valley
- Investigators
- Isabel Paz, MSc, Principal investigator, University of Vale dos Sinos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636799
- Sponsor's protocol ID
- 6.584.696
- Status last verified
- Oct 2024
- First submitted
- 20 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF MICRONEEDLING ON CLINICAL PARAMETERS OF STRIAE ALBA AND MORPHOLOGICAL PARAMETERS OF THE FEMALE TEGUMENTARY SYSTEM: A RANDOMIZED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT06636799
- Acronym / sponsor ID
- 6.584.696
- Conditions
- Striae; Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Isabel de Almeida PazUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 15 Oct 2024 (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.
Stretch marks are dermal scars of multifactorial etiology, for which several treatments have been proposed. Among these is microneedling (MN), a technique that stimulates collagen production. However, the effects of MA alone and in combination with active agents on the length and area of stretch marks and the thickness of the integumentary system are not well understood, as the literature is scarce. Therefore, the objectives of this study were: To assess the effects of MA alone and in combination with active agents (growth factors, hyaluronic acid, and Hydroxyprolisilane CN®️) on clinical parameters (area and length) of stretch marks and morphological parameters (dermal and hypodermal thickness) of the female integumentary system. The sample was randomized into a control group (G1) that did not receive treatment, G2 that received MN alone, and G3 that received MN combined with active agents. Groups G2 and G3 underwent 3 sessions of the protocol with a 4-week interval. Groups were evaluated at the beginning and 4 months after the start of the protocol. Evaluation of the area and length of stretch marks was performed through photography, dermal and hypodermal thickness was assessed via ultrasonography, and satisfaction levels were measured using the Likert scale.
Detailed description
This study was a randomized clinical trial in blocks with a 1:1 allocation, stratified by weight. The study was duly adapted to resolution 466/12 of the National Health Council on research involving human beings and to the Declaration of Helsinki. The evaluations and treatment protocols were carried out at the Physiotherapy Clinic of a Private Higher Education Institution.. The sample was characterized by convenience and healthy women who met the inclusion criteria were recruited, mainly via social networks. To calculate the sample size, the G-Power software (version 3.1.3; University of Trier, Trier, Germany) was used and the significance level adopted was α = 0.05 and power (1-β) = 0.80. No similar studies were found, so f 0.30 was used as the effect size. Therefore, the minimum number of participants required for the study was estimated at 24 participants. Considering possible losses during the protocol, 26 participants (+10%) were recruited. Randomization was performed by stratifying by weight. The randomization list was kept in opaque and sealed envelopes, ensuring that the allocation was hidden and random and that the therapist responsible for applying the microneedling had contact with the randomization only on the day of the protocol application. In the present study, the sample of 26 participants was divided into three groups. Group one (G1), control, composed of eight people, underwent all the evaluations, but did not receive the microneedling protocol or actives. Group two (G2), composed of nine people, underwent all the proposed evaluations and the isolated microneedling procedure. Group three (G3), composed of nine people, underwent all the proposed evaluations and the microneedling procedure associated with actives. Groups G2 and G3 underwent 3 sessions of the protocol with a 4-week interval. Groups were evaluated at the beginning and 4 months after the start of the protocol. Evaluation of the area and length of stretch marks was performed through photography, dermal and hypodermal thickness was assessed via ultrasonography, and satisfaction levels were measured using the Likert scale.This study adopted the intention-to-treat approach. Therefore, participants who did not attend the scheduled sessions were rescheduled, allowing all sessions planned to be carried out. When the decision was made to withdraw, the data collected up until the end were used for analysis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Microneedling only | Experimental | Device: Microneedling onlyIn this procedure, only the derma roller composed of 1.5 mm microneedles from the Smart Derma Roller brand with 540 titanium needles was used. |
| Microneedling associated with actives | Active comparator | Other: Microneedling and activesIn this procedure, a derma roller composed of 1.5 mm microneedles from the Smart Derma Roller brand with 540 titanium needles associated with active ingredients were used. |
| Control | No intervention | –This group did not receive intervention but participated in pre- and post-protocol assessments. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy women (self-declaration of no diseases)
- Age between 18 and 35 years
- Presence of striae alba in the gluteal region
Key exclusion criteria (11 listed)
- Health problems (cardiovascular, neurological, or musculoskeletal impairment)
- History of keloids
- Allergic disorders
- Skin cancer
- Systemic disease
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 |
|---|---|---|
| Microneedling onlyIn this procedure, a derma roller composed of 1.5 mm microneedles from the Smart Derma Roller brand with 540 titanium needles was used. The protocol was performed by passing the derma roller ten times in the following directions: horizontal, vertical, and diagonal right and left. | Device | Microneedling only |
| Microneedling and activesIn this procedure, a derma roller composed of 1.5 mm microneedles from the Smart Derma Roller brand with 540 titanium needles was used. The protocol was performed by passing the derma roller ten times in the following directions: horizontal, vertical, and diagonal right and left. Group G3 received microneedling associated with active ingredients. This manipulated active ingredient was composed of growth factors (EGF Factor, TGFß3 Factor, and IDP-2 Peptide), Hydroxyprolisilane, and hyaluronic acid. | Other | Microneedling associated with actives |
Primary outcome
The area of stretch marks
Time frame: 30 minutes
Photographic image analysis was performed before and after the protocol.These images will be analyzed later by tracing the area of the entire stria.
The thickness of stretch marks
Time frame: 30 minutes
Photographic image analysis was performed before and after the protocol. These images will be analyzed later by drawing a line between the upper and lower edges of the stria.
3 secondary outcomes
Skin thickness
Time frame: 30 minutes
Likert scale of patient satisfaction
Time frame: 20 minutes
Hypodermis thickness
Time frame: 30 minutes
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 15 Oct 2024.
- Individual participant dataSharing planned: Undecided
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.
Isabel Paz, MSc principal investigator
University of Vale dos Sinos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedling only and Microneedling and actives in people with Striae; Atrophy, run by Isabel de Almeida Paz 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 3 inclusion and 11 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 15 Oct 2024. 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?
The area of stretch marks (time frame: 30 minutes). 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?
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 15 Oct 2024.