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Completed

NCT Number: NCT06492356

Impact of Tripolar Radiofrequency on Acne Scar

The aim of this study is to investigate the therapeutic efficacy of tripolar radiofrequency on acne scar

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Key information

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic Cicatrix Fibrosis Hypertrophy Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Radiofrequency Scar

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malawy Specialized Hospital

Minya, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • Recurrent herpes viral infection.
  • Pregnancy or breastfeeding status.
  • Females take contraceptive pills
  • Hormonal disturbance

Treatment and study plan

Tripolar radiofrequency therapy

Device

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 treatment

Drug

Twenty patients will receive medical treatment by dermatologist.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Assessing the quantitative measurement of the acne scars

    Time frame: at base line and following 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 9, 2024
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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