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Efficacy of low dose oral Isotretinoin combination with fractional radiofrequency Microneedling versus low dose oral isotretinoin alone in the treatment of moderate to severe acne vulgaris : A randomized controlled comparative study

Efficacy of low dose oral Isotretinoin combination with fractional radiofrequency Microneedling versus low dose oral isotretinoin alone in the treatment of moderate to severe acne vulgaris : A randomized controlled comparative study

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250202008
Enrollment
78
Registered
2025-02-02
Start date
2023-08-23
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Efficacy of low dose oral Isotretinoin combination with fractional radiofrequency microneedling in moderate to severe acne vulgaris Low dose isotretinoin, Radiofrequency microneedling, Acne vulgaris

Interventions

Fractional Radiofrequency Microneedling is a novel radiofrequency technique that deliver energy to controllable depth of the skin.The intervention provides microtrauma to cutaneous tissues and generat
Fractional Radiofrequency Microneedling and low dose isotretinoin,low dose isotretinoin

Sponsors

Thammasat University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Males and females aged between 18 and 50 years old, specifically those diagnosed with moderate to severe Acne Vulgaris according to the Global Acne Grading System, were included in the study. 2. Women who are menstruating must be advised on contraceptive measures and use contraceptive methods such as condoms or intrauterine devices

Exclusion criteria

Exclusion criteria: 1. Individuals with underlying skin conditions, such as atopic dermatitis, psoriasis, vitiligo, or other underlying diseases that may cause skin abnormalities, such as diabetes mellitus, chronic renal failure, cirrhosis, or porphyria. 2. Individuals who are pregnant, planning to become pregnant, or breastfeeding. 3. Individuals with underlying diseases related to immune system dysfunction, such as primary immunodeficiencies, HIV, anaphylaxis, asthma, generalized drug reactions, lymphoma, leukemia, rheumatoid arthritis, or systemic lupus erythematosus. 4. Individuals with underlying conditions, including hyperlipidemia, liver disease, kidney disease, malnutrition, or polycystic ovary syndrome (PCOS). 5. Individuals who have previously undergone treatments with 1,450-nm diode laser, 595-nm pulsed dye laser, intense pulsed light photodynamic therapy, non-ablative erbium glass fractional laser, or ablative 10,600-nm carbon dioxide fractional laser within the 6 months prior to starting the study. 6. Individuals with a history of keloids or a tendency to develop keloids easily. 7. Individuals who have used isotretinoin or combined hormonal contraceptives within the last 6 months. 8. Individuals who have stopped using steroids less than 3 months before starting the study. 9. Individuals who have stopped using acne treatment medications, oral antibiotics, or topical acne medications less than 4 weeks before starting the study.

Design outcomes

Primary

MeasureTime frame
Acne count 0,12,20,24,32,44 week Global Acne Grading score

Secondary

MeasureTime frame
Texture, Hemoglobin 0,12,20,24,32,44 week Antera 3D

Countries

Thailand

Contacts

Public ContactWareeporn Disphanurat

Thammasat University Hospital

dwareeporn@gmail.com029259435

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026