Acne Scars - Mixed Atrophic and HypertrophicNCT06492356
Impact of Tripolar Radiofrequency on Acne Scar
A study testing Tripolar radiofrequency therapy and medical treatment in people with Acne Scars - Mixed Atrophic and Hypertrophic and Scar, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to investigate the therapeutic efficacy of tripolar radiofrequency on acne scar Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Acne Scars - Mixed Atrophic and Hypertrophic, Scar, Radiofrequency
- What is being tested?
- Tripolar radiofrequency therapy and medical treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 Jun 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Forty patients having acne scar, from both genders their ages will be ranged from 20 to 40 years old
- Both genders will participate in this study as the following distribution 17 male and 23 female.
- They diagnosed as acne scar by their physicians and referred for physical therapy management.
- Medically and psychologically stable patients.
- All patients will approve and sign a consent form before starting the program which will include the purpose, natures and potential risks of the study which will be explained to all patients
Who cannot join
- Patients who suffer from hypertrophic and/or keloidal scars and a skin condition in the area of acne scars that would interfere with study procedures (e.g., plaque psoriasis, tattoo, birthmark, facial hair).
- Patients with medical red flags as severe psychiatric disorder or cognitive deficits.
- Medically unstable and uncooperative patients.
- Untreated and active/ongoing acne vulgaris.
- Immunocompromised status.
- History of skin cancer.
Show all 10Show fewer
- Recurrent herpes viral infection.
- Pregnancy or breastfeeding status.
- Females take contraceptive pills
- Hormonal disturbance
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the therapeutic efficacy of tripolar radiofrequency on acne scar
Read the detailed description
Acne scarring is a very troublesome complication associated with acne and is reported in as high as 95% of the patients, sometimes even with proper and prompt treatment. The visible depressed scars have been known to have a negative impact on patient's psychological well-being and quality of life. Post acne scarring can pose as a risk factor for depression, anxiety, and even suicide (Villani, 2020).
There are a multitude of treatment options that are traditionally used for the treatment of acne scars including many ablative and non-ablative methods (Dogra, 2014).
Furth more, the need of this study is developed from the lack in quantitative knowledge and information in the published studies which investigate the effect of tripollar RF This study will be designed to provide guidelines about the effect tripollar Radiofrequency on acne scars.
- Being tested
- Tripolar radiofrequency therapy, medical treatment
- Medical subject headings
- Hypertrophy, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tripolar radiofrequency therapyDevice
Twenty patients underwent weekly TriPollar RF treatment, using a new RF technology with three or more electrodes. Glycerin was applied to the treatment area before and after each session, with the procedure lasting 15 minutes. The technology uses a sequence of electrical modulation to prevent overheating and requires no active cooling of the electrodes or skin.
medical treatmentDrug
Twenty patients will receive medical treatment by dermatologist.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Consists of 20 patients with acne scars and will receive medical treatment by a dermatologist and tripolar radiofrequency (RF) therapy once a week for 12 weeks, each session for 15 minutes. Receives: Device: Tripolar radiofrequency therapy; Drug: medical treatment |
| Group B | Active comparator | consists of 20 patients with acne scars and will receive medical treatment by a dermatologist Receives: Drug: medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the change in severity of acne scars
SCARS is a 5-item instrument designed to rate the severity of acne scars in a mirror. It uses visual analog scales to differentiate between active and scars. The tool is self-completion and can be completed quickly. Patients are photographed at the beginning and after 12 treatment sessions. SCARS scores range from 0 to 4, with higher scores indicating greater severity. It captures demographic information and clinical characteristics of acne and scarring.
Measured: at base line and following 12 weeks
Secondary outcomes (1)
Assessing the quantitative measurement of the acne scars
Dey et al. developed an automatic approach to quantify acne scars using color images, achieving a sensitivity of 90.36 and specificity of 93.82. However, this method does not allow for volumetric assessment of the scar. Another technique, proposed by Petukhova et al., uses three-dimensional photographic images to construct a topographic map, which is then objectively calculated for each scar. This method does not assess color changes like dyspigmentation, which is essential for tracking scars over time. Further testing is needed to improve this method.
Measured: at base line and following 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Jul 2023
- Primary completion1 Dec 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne Scars - Mixed Atrophic and HypertrophicStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- single-blinded randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshymaa Ahmed Kamel Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492356
- Sponsor's protocol ID
- Alshymaa M.sc
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Tripolar Radiofrequency on Acne Scar
- ClinicalTrials.gov ID
- NCT06492356
- Acronym / sponsor ID
- Alshymaa M.sc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 9 Jul 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.
The aim of this study is to investigate the therapeutic efficacy of tripolar radiofrequency on acne scar
Detailed description
Acne scarring is a very troublesome complication associated with acne and is reported in as high as 95% of the patients, sometimes even with proper and prompt treatment. The visible depressed scars have been known to have a negative impact on patient's psychological well-being and quality of life. Post acne scarring can pose as a risk factor for depression, anxiety, and even suicide (Villani, 2020).
There are a multitude of treatment options that are traditionally used for the treatment of acne scars including many ablative and non-ablative methods (Dogra, 2014).
Furth more, the need of this study is developed from the lack in quantitative knowledge and information in the published studies which investigate the effect of tripollar RF This study will be designed to provide guidelines about the effect tripollar Radiofrequency on acne scars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- single-blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Tripolar radiofrequency therapy, Drug: medical treatmentConsists of 20 patients with acne scars and will receive medical treatment by a dermatologist and tripolar radiofrequency (RF) therapy once a week for 12 weeks, each session for 15 minutes. |
| Group B | Active comparator | Drug: medical treatmentconsists of 20 patients with acne scars and will receive medical treatment by a dermatologist |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Forty patients having acne scar, from both genders their ages will be ranged from 20 to 40 years old
- Both genders will participate in this study as the following distribution 17 male and 23 female.
- They diagnosed as acne scar by their physicians and referred for physical therapy management.
- Medically and psychologically stable patients.
- All patients will approve and sign a consent form before starting the program which will include the purpose, natures and potential risks of the study which will be explained to all patients
Key exclusion criteria (10 listed)
- Patients who suffer from hypertrophic and/or keloidal scars and a skin condition in the area of acne scars that would interfere with study procedures (e.g., plaque psoriasis, tattoo, birthmark, facial hair).
- Patients with medical red flags as severe psychiatric disorder or cognitive deficits.
- Medically unstable and uncooperative patients.
- Untreated and active/ongoing acne vulgaris.
- Immunocompromised status.
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 |
|---|---|---|
| Tripolar radiofrequency therapyTwenty patients underwent weekly TriPollar RF treatment, using a new RF technology with three or more electrodes. Glycerin was applied to the treatment area before and after each session, with the procedure lasting 15 minutes. The technology uses a sequence of electrical modulation to prevent overheating and requires no active cooling of the electrodes or skin. | Device | Group A |
| medical treatmentTwenty patients will receive medical treatment by dermatologist. | Drug | Group A, Group B |
Primary outcome
Assessing the change in severity of acne scars
Time frame: at base line and following 12 weeks
SCARS is a 5-item instrument designed to rate the severity of acne scars in a mirror. It uses visual analog scales to differentiate between active and scars. The tool is self-completion and can be completed quickly. Patients are photographed at the beginning and after 12 treatment sessions. SCARS scores range from 0 to 4, with higher scores indicating greater severity. It captures demographic information and clinical characteristics of acne and scarring.
1 secondary outcome
Assessing the quantitative measurement of the acne scars
Time frame: at base line and following 12 weeks
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 11 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tripolar radiofrequency therapy and medical treatment in people with Acne Scars - Mixed Atrophic and Hypertrophic and Scar, run by Cairo University at 1 site in Egypt.
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 10 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 11 Jul 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 Egypt. 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?
Assessing the change in severity of acne scars (time frame: at base line and following 12 weeks). 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 11 Jul 2024.