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Fractional Radiofrequency Microneedling Combined With Low-Dose Isotretinoin Versus Standard-Dose Isotretinoin in Moderate-to-Severe Acne A Randomized Controlled Pilot Study

Fractional Radiofrequency Microneedling Combined With Low-Dose Isotretinoin Versus Standard-Dose Isotretinoin in Moderate-to-Severe Acne A Randomized Controlled Pilot StudyFractional Radiofrequency Microneedling Combined With Low-Dose Isotretinoin Versus Standard-Dose Isotretinoin in Moderate-to-Severe Acne A Randomized Controlled Pilot Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125772
Enrollment
Unknown
Registered
2026-05-31
Start date
2026-05-31
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne

Interventions

Group A:Received a fixed daily dose of 20 mg isotretinoin, which resulted in an actual dose range of 0.18 to 0.36 mg/kg/day based on their weight between 55 and 110 kg. The patients also received frac
Group B:Received standard weight-based isotretinoin at 0.5 mg/kg/day

Sponsors

University of Mosul
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 33 Years

Inclusion criteria

Inclusion criteria: The study included patients aged 18 to 33 years with moderate-to-severe acne vulgaris of the face, as defined by an Investigator Global Assessment (IGA) score of 3 or 4. All patients had failed or were unsuitable for conventional topical therapy alone.

Exclusion criteria

Exclusion criteria: Patients were excluded from the study when they met any of these criteria: 1.They had used isotretinoin during the last 12 months; 2.They had documented hypersensitivity to retinoids; 3.They were currently suffering from active hepatic or renal or metabolic diseases; 4.Females were pregnant or they refused to follow birth control rules; 5.They had an existing skin infection at the sites where RF treatment was scheduled; 6.They had received RF microneedling treatment within the 6 months before their enrollment date.

Design outcomes

Primary

MeasureTime frame
Change in Investigator's Global Assessment (IGA) score from baseline to week 16, on a validated 5-point scale (0 = clear, 4 = severe);

Secondary

MeasureTime frame
counting inflammatory lesions at week 8 and at the end of the trial (EOT); ;Assessing treatment failure rate at 6 months, which occurred when IGA score remained above 2;Evaluating safety and tolerability through the documented adverse events.;Change in Patient Satisfaction Score (PSS) on a 10-point Likert scale at week 8;

Countries

Iraq

Contacts

Public ContactAhmed M. Al Obaidi

University of Mosul

qasimalchalabi@uomosul.edu.iq+964 770 161 8688

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026