Skip to content

The Impact of Fish Oil Supplementation on the Efficacy and Side Effects of Low-dose Isotretinoin in Treatment of Moderate-to-severe Acne Vulgaris Compared to Low-dose Isotretinoin Monotherapy

Impact of fish oil on efficacy and side effects of low-dose isotretinoin in treatment of moderate to severe acne vulgaris: A Double-blinded Randomized Controlled Trial.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240810002
Enrollment
80
Registered
2024-08-10
Start date
2024-06-03
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

male or female patients aged 18-25 years with moderate to severe acne vulgaris acne, isotretinoin, fish oil, mucocutaneous side effects

Interventions

the group receiving fish oil: take 1 capsule of fish oil and 1 soft capsule of 10 mg isotretinoin after meal once daily for 3 months ,the group receiving placebo: take 1 capsule of placebo and 1 soft
fish oil (study product),placebo

Sponsors

Ratchadapiseksompotch Fund Chulalongkorn university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 25 Years

Inclusion criteria

Inclusion criteria: 1. male or female, aged 18-25 years, diagnosed with moderate to severe acne vulgaris 2. BMI < 29.9 3. ability to follow research protocols

Exclusion criteria

Exclusion criteria: 1. Individuals with a history of used topical treatment for acne vulgaris within a past month 2. Those who have documented allergy to isotretinoin 3. individuals with a history of taking fish oil supplements within the past 3 months 4. Those who have undergone procedures or treatments for acne with any options 5. individuals with diseases associated with acne, such as PCOS 6. on current medication that impacts acne, such as corticosteroids, JAK inhibitors 7. individuals with dyslipidemia, liver disease 8. bleeding tendency 9. pregnant or breastfeeding women.

Design outcomes

Primary

MeasureTime frame
impact of fish oil on efficacy of isotretinoin in acne improvement. baseline, 1 month, 2 months, 3 months the outcome was based on the investigator global assessment (IGA) score and the lesion counts (both inflammatory and non-inflammatory) on the entire face.

Secondary

MeasureTime frame
impact of fish oil on side effects of isotretinoin (mucocutaneous dryness) was measured by 1) skin hydration baseline, 1 month, 2months, 3 months assessing epidermal hydration by using corneometer (measures skin capacitance, which directly varies with hydration) apply on cheek.,impact of fish oil on side effects of isotretinoin (mucocutaneous dryness) was measured by 2) transepidermal water loss baseline, 1 month, 2months, 3 months TEWA meter (g/m2/hr),impact of fish oil on side effects of isotretinoin (mucocutaneous dryness) was measured by 3) sebum level of skin surface baseline, 1 month, 2months, 3 months sebumeter,impact of fish oil on side effects of isotretinoin (mucocutaneous dryness) was measured by 4) skin pH baseline, 1 month, 2months, 3 months pH meter,impact of fish oil on side effects of isotretinoin (hypertriglyceridemia). baseline, 3 months blood for lipid profiles,impact of fish oil on side effects of isotretinoin (elevated liver enzymes). baseline, 3 months blood for AST, ALT,impact of fish oil on side effects of isotretinoin (mucocutaneous dryness) was evaluated using 5) questionnaires. 1 month, 2months, 3 months questionnaires by Patients

Countries

Thailand

Contacts

Public ContactChanat Kumtornrut

Faculty of Medicine Chulalongkorn University

chanat_1@yahoo.com66814595965

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026