Impact of Tripolar Radiofrequency on Acne Scar

NCT06492356 | Completed

• 1 other identifier: Alshymaa M.sc
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic; Scar; Radiofrequency

Outcome Measures

Primary Outcomes (1)

• 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.

  at base line and following 12 weeks

Secondary Outcomes (1)

• Assessing the quantitative measurement of the acne scars

  at base line and following 12 weeks

Study Arms (2)

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.

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

Drug: medical treatment

Interventions

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.

Group A

medical treatment DRUG

Twenty patients will receive medical treatment by dermatologist.

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Malawy Specialized Hospital

Minya, Egypt

Location

MeSH Terms

Conditions

Hypertrophy; Cicatrix

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Fibrosis; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: single-blinded randomized controlled trial

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: July 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

EG (1)