AcnePhase 3Omega-3NCT01764308
Effects of Omega-3 Fatty Acid Supplementation in Acne Patients
A Phase 3 study testing Omega-3 in people with Acne, run by University of California, Los Angeles at 1 site in United States.
Trial summary
60 patients receiving isotretinoin will be recruited from the UCLA acne specialty clinic. Subjects will be randomized in a 1:1 ratio to receive placebo or omega-3 1200mg twice a day for 24 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- Omega-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 31 Mar 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female above 18 years of age.
- Moderate to severe disease at the baseline of the study identified by their dermatologist.
- Will start treatment with systemic therapy for acne in the form of either isotretinoin or oral antibiotics.
- Patients able and willing to comply with the procedures in the study protocol.
Who cannot join
- Patients with history of taking omega-3 supplements for high triglyceride levels.
- Patients taking medications for dyslipidemia, blood thinners, or high blood pressure medication.
- Patients with a history of adverse reaction to omega-3 fatty acid supplementation.
- Unwilling to give inform consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Califonia, Los Angeles Division of Dermatology
Los Angeles, California, 90095
About this study
Official title: Omega-3 Fatty Acid Supplementation in Acne Patients
60 patients receiving isotretinoin will be recruited from the UCLA acne specialty clinic. Subjects will be randomized in a 1:1 ratio to receive placebo or omega-3 1200mg twice a day for 24 weeks.
Read the detailed description
Experimental Design
60 patients receiving isotretinoin will be recruited from the UCLA acne specialty clinic. Subjects will be randomized in a 1:1 ratio to receive placebo or omega-3 1200mg twice a day for 24 weeks.
Inclusion Criteria:
- Male or female above 18 years of age.
- Moderate to severe disease at the baseline of the study identified by their dermatologist.
- Will start treatment with systemic therapy for acne in the form of either isotretinoin or oral antibiotics.
- Patients able and willing to comply with the procedures in the study protocol.
Exclusion Criteria:
- Patients with history of taking omega-3 supplements for high triglyceride levels.
- Patients taking medications for dyslipidemia, blood thinners, or high blood pressure medication.
- Patients with a history of adverse reaction to omega-3 fatty acid supplementation.
- Unwilling to give inform consent
First Visit (Baseline)
All patients will complete an intake survey. This survey will include self-assessment via Leed's standardized photo scale, and the Skindex 16 quality of life questionnaire.
Physicians will complete acne assessment on all patients. This includes lesion counts, standardized Leed's photo scale and global assessment scale 0-5.
Fasting blood sample will be obtained for chemistry and lipid panel if being treated with isotretinoin, as is standard for this therapy.
Follow-up visits at weeks 8, 16, 24:
Patients will come in at weeks 8, 16 and 24 for the following procedures:
All patients will fill out follow-up survey at each visit. The survey will elicit information regarding compliance with medication, compliance with supplementation, side effects of supplementation, side effects of acne therapy, and satisfaction with therapy.
Follow-up surveys will include patient self assessment with Leed's photo scale, and Skindex 16 questionnaire.
Physicians will complete acne assessment on all patients. This includes lesion counts, photo scale and global assessment (Grade 0-5). See attached "Physician checklist."
Patients will have fasting blood drawn for lipid panel if being treated with isotretinoin, as is standard for this therapy.
Data analysis:
In all study patients being treated for acne, lesion counts will be assessed and evaluated for any differences between patients on omega-3 fatty acid supplementation and not on supplementation.
Global assessment, photo scale assessment and Skindex-16 quality of life assessment will be compared between patients with and without supplementation.
We will compare triglyceride levels in patients being treated with isotretinoin with and without omega-3 fatty acid supplementation.
Overall satisfaction with therapy will be compared between patients with O3FA supplementation and without supplementation.
- Conditions
- Acne
- Being tested
- Omega-3, Placebo
- Keywords
- acne; omega-3; isotretinoin; placebo
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
Also called Omega-3 fatty acid; fish oil supplement; alpha-linolenic acid
1200mg twice a day for 24 weeks
PlaceboDietary supplement
Also called Sugar pill
4 tablets twice a day for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| O3FA | Experimental | Omega 3 Fatty Acid 1200mg twice a day for 24 weeks Receives: Dietary Supplement: Omega-3; Dietary Supplement: Placebo |
| Placebo | Placebo comparator | 4 tablets twice a day for 24 weeks Receives: Dietary Supplement: Omega-3; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acne Lesion Count
In all study patients being treated for acne, lesion counts will be assessed and evaluated for any differences between patients on omega-3 fatty acid supplementation and not on supplementation.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startJan 2013
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Why it stopped: insufficient staff to complete recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Kim, MD, Kaiser Permanente
- Investigators
- Christina N Kim, MD, Principal investigator, Kaiser PermanenteCarolyn Goh, MD, Study chair, UCLA Division of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764308
- Sponsor's protocol ID
- O3FA
- Acronym
- Omega-3
- Status last verified
- Apr 2019
- First submitted
- 7 Jan 2013
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acid Supplementation in Acne Patients
- ClinicalTrials.gov ID
- NCT01764308
- Acronym / sponsor ID
- Omega-3 / O3FA
- Conditions
- Acne
- Keywords
- acne; omega-3; isotretinoin; placebo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient staff to complete recruitment
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 9 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
60 patients receiving isotretinoin will be recruited from the UCLA acne specialty clinic. Subjects will be randomized in a 1:1 ratio to receive placebo or omega-3 1200mg twice a day for 24 weeks.
Detailed description
Experimental Design
60 patients receiving isotretinoin will be recruited from the UCLA acne specialty clinic. Subjects will be randomized in a 1:1 ratio to receive placebo or omega-3 1200mg twice a day for 24 weeks.
Inclusion Criteria:
- Male or female above 18 years of age.
- Moderate to severe disease at the baseline of the study identified by their dermatologist.
- Will start treatment with systemic therapy for acne in the form of either isotretinoin or oral antibiotics.
- Patients able and willing to comply with the procedures in the study protocol.
Exclusion Criteria:
- Patients with history of taking omega-3 supplements for high triglyceride levels.
- Patients taking medications for dyslipidemia, blood thinners, or high blood pressure medication.
- Patients with a history of adverse reaction to omega-3 fatty acid supplementation.
- Unwilling to give inform consent
First Visit (Baseline)
All patients will complete an intake survey. This survey will include self-assessment via Leed's standardized photo scale, and the Skindex 16 quality of life questionnaire.
Physicians will complete acne assessment on all patients. This includes lesion counts, standardized Leed's photo scale and global assessment scale 0-5.
Fasting blood sample will be obtained for chemistry and lipid panel if being treated with isotretinoin, as is standard for this therapy.
Follow-up visits at weeks 8, 16, 24:
Patients will come in at weeks 8, 16 and 24 for the following procedures:
All patients will fill out follow-up survey at each visit. The survey will elicit information regarding compliance with medication, compliance with supplementation, side effects of supplementation, side effects of acne therapy, and satisfaction with therapy.
Follow-up surveys will include patient self assessment with Leed's photo scale, and Skindex 16 questionnaire.
Physicians will complete acne assessment on all patients. This includes lesion counts, photo scale and global assessment (Grade 0-5). See attached "Physician checklist."
Patients will have fasting blood drawn for lipid panel if being treated with isotretinoin, as is standard for this therapy.
Data analysis:
In all study patients being treated for acne, lesion counts will be assessed and evaluated for any differences between patients on omega-3 fatty acid supplementation and not on supplementation.
Global assessment, photo scale assessment and Skindex-16 quality of life assessment will be compared between patients with and without supplementation.
We will compare triglyceride levels in patients being treated with isotretinoin with and without omega-3 fatty acid supplementation.
Overall satisfaction with therapy will be compared between patients with O3FA supplementation and without supplementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| O3FA | Experimental | Dietary Supplement: Omega-3, Dietary Supplement: PlaceboOmega 3 Fatty Acid 1200mg twice a day for 24 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Omega-3, Dietary Supplement: Placebo4 tablets twice a day for 24 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female above 18 years of age.
- Moderate to severe disease at the baseline of the study identified by their dermatologist.
- Will start treatment with systemic therapy for acne in the form of either isotretinoin or oral antibiotics.
- Patients able and willing to comply with the procedures in the study protocol.
Key exclusion criteria (4 listed)
- Patients with history of taking omega-3 supplements for high triglyceride levels.
- Patients taking medications for dyslipidemia, blood thinners, or high blood pressure medication.
- Patients with a history of adverse reaction to omega-3 fatty acid supplementation.
- Unwilling to give inform consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3Also: Omega-3 fatty acid; fish oil supplement; alpha-linolenic acid1200mg twice a day for 24 weeks | Dietary supplement | O3FA, Placebo |
| PlaceboAlso: Sugar pill4 tablets twice a day for 24 weeks | Dietary supplement | O3FA, Placebo |
Primary outcome
Acne Lesion Count
Time frame: up to 24 weeks
In all study patients being treated for acne, lesion counts will be assessed and evaluated for any differences between patients on omega-3 fatty acid supplementation and not on supplementation.
Results and safety
The study was stopped early (reason given: insufficient staff to complete recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina N Kim, MD principal investigator
Kaiser Permanente
Carolyn Goh, MD study chair
UCLA Division of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omega-3 in people with Acne, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: insufficient staff to complete recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acne Lesion Count (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.