AcneAcneNCT02180425
The Lipid Profile of the Skin Surface in Acne
An observational study of Acne, run by University of California, Davis at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the differences in the skin lipid profile of patients with and without acne. Secondly, the goal is to learn more about what the effects of retinoinds (topical and systemic) are on the the skin lipid profile. Read more about this study
- Who is it for?
- Ages 12 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- Tretinoin or Adapalene and Isotretinoin
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2013to Jul 2015
- Phase
- Observational
- 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 12 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Subjects will be from the UC Davis Dermatology Clinic, surrounding dermatology clinics, from the UC Davis undergraduate campus, and from the California State University Sacramento campus.
Who may be able to join
- age 12 to 30 years
- have been prescribed tretinoin OR isotretinoin
Who cannot join
- those who have taken isotretinoin (systemic)
- those who used tretinoin or other topical retinoid within two weeks of starting the study
- those with seborrheic dermatitis, rosacea, or polycystic ovary syndrome
- those who are pregnant, prisoners, or cognitively impaired
- those who do not fit the inclusion criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dermatology Research Area
Davis, California, 95616
UC Davis Department of Dermatology
Sacramento, California, 95816
About this study
The purpose of this study is to evaluate the differences in the skin lipid profile of patients with and without acne. Secondly, the goal is to learn more about what the effects of retinoinds (topical and systemic) are on the the skin lipid profile. We hypothesize that the skin lipid profile of subjects with acne will be lower in inflammatory lipids in comparison to subjects without acne.
Read the detailed description
Skin lipid profile will be conducted via sebutapes- adhesive tapes that painlessly absorbs sebum from the face. These tapes will be placed on the face for 1 hour. A photograph of the face will be taken during each study visit. A sebumeter will also be used to measure skin sebum secretion rate.
- Conditions
- Acne
- Being tested
- Tretinoin or Adapalene, Isotretinoin
- Keywords
- acne, lipid, tretinoin, isotretinoin
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tretinoin or AdapaleneDrug
Also called Retin A
Subjects will apply a pea sized amount of topical retinoid cream once daily at night for 30 days. Subjects will return for a follow-up visit.
IsotretinoinDrug
Also called Accutane
Subjects will take one pill once daily for 5 months. Subjects will return after 1 month and after 4-5 months of treatment for skin lipid profiling.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Group | The subjects in this group do not have a history of acne. | |
| Acne Group, Topical Retinoid | These subjects have been prescribed a topical retinoid for their acne. They will participate in the study for a period of 1 month. Receives: Drug: Tretinoin or Adapalene | |
| Acne Group, Isotretinoin | These subjects have been prescribed isotretinoin for their acne. They will participate in the study for a period of 5-6 months. Receives: Drug: Isotretinoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin lipid profile of acne and healthy patients
Compare the skin lipid profile of acne and healthy patients at baseline
Measured: baseline visit
Secondary outcomes (1)
Skin lipid profile of acne patients after treatment
Patients in the topical retinoid group will have their lipids evaluated after 1 month of treatment. Patients in the systemic retinoid (isotretinoin) group will have their lipids evaluated after 1 and 4-5 months of treatment.
Measured: at 1 month and 4-5 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startNov 2013
- Primary completionMay 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raja K Sivamani, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180425
- Sponsor's protocol ID
- 531506
- Acronym
- Acne
- Status last verified
- May 2017
- First submitted
- 30 Jun 2014
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Thody AJ, Shuster S. Control and function of sebaceous glands. Physiol Rev. 1989 Apr;69(2):383-416. doi: 10.1152/physrev.1989.69.2.383.
PubMed 2648418Blume U, Verschoore M, Poncet M, Czernielewski J, Orfanos CE, Schaefer H. The vellus hair follicle in acne: hair growth and sebum excretion. Br J Dermatol. 1993 Jul;129(1):23-7. doi: 10.1111/j.1365-2133.1993.tb03306.x.
PubMed 8369207Zouboulis CC, Baron JM, Bohm M, Kippenberger S, Kurzen H, Reichrath J, Thielitz A. Frontiers in sebaceous gland biology and pathology. Exp Dermatol. 2008 Jun;17(6):542-51. doi: 10.1111/j.1600-0625.2008.00725.x.
PubMed 18474083Doshi A, Zaheer A, Stiller MJ. A comparison of current acne grading systems and proposal of a novel system. Int J Dermatol. 1997 Jun;36(6):416-8. doi: 10.1046/j.1365-4362.1997.00099.x. No abstract available.
PubMed 9248884Morello AM, Downing DT, Strauss JS. Octadecadienoic acids in the skin surface lipids of acne patients and normal subjects. J Invest Dermatol. 1976 May;66(5):319-23. doi: 10.1111/1523-1747.ep12482300.
PubMed 131844
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lipid Profile of the Skin Surface in Acne
- ClinicalTrials.gov ID
- NCT02180425
- Acronym / sponsor ID
- Acne / 531506
- Conditions
- Acne
- Keywords
- acne, lipid, tretinoin, isotretinoin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 2 Jul 2014 (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.
The purpose of this study is to evaluate the differences in the skin lipid profile of patients with and without acne. Secondly, the goal is to learn more about what the effects of retinoinds (topical and systemic) are on the the skin lipid profile. We hypothesize that the skin lipid profile of subjects with acne will be lower in inflammatory lipids in comparison to subjects without acne.
Detailed description
Skin lipid profile will be conducted via sebutapes- adhesive tapes that painlessly absorbs sebum from the face. These tapes will be placed on the face for 1 hour. A photograph of the face will be taken during each study visit. A sebumeter will also be used to measure skin sebum secretion rate.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Group | – | –The subjects in this group do not have a history of acne. |
| Acne Group, Topical Retinoid | – | Drug: Tretinoin or AdapaleneThese subjects have been prescribed a topical retinoid for their acne. They will participate in the study for a period of 1 month. |
| Acne Group, Isotretinoin | – | Drug: IsotretinoinThese subjects have been prescribed isotretinoin for their acne. They will participate in the study for a period of 5-6 months. |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Subjects will be from the UC Davis Dermatology Clinic, surrounding dermatology clinics, from the UC Davis undergraduate campus, and from the California State University Sacramento campus.
Key inclusion criteria (2 listed)
- age 12 to 30 years
- have been prescribed tretinoin OR isotretinoin
Key exclusion criteria (5 listed)
- those who have taken isotretinoin (systemic)
- those who used tretinoin or other topical retinoid within two weeks of starting the study
- those with seborrheic dermatitis, rosacea, or polycystic ovary syndrome
- those who are pregnant, prisoners, or cognitively impaired
- those who do not fit the inclusion criteria
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 |
|---|---|---|
| Tretinoin or AdapaleneAlso: Retin ASubjects will apply a pea sized amount of topical retinoid cream once daily at night for 30 days. Subjects will return for a follow-up visit. | Drug | Acne Group, Topical Retinoid |
| IsotretinoinAlso: AccutaneSubjects will take one pill once daily for 5 months. Subjects will return after 1 month and after 4-5 months of treatment for skin lipid profiling. | Drug | Acne Group, Isotretinoin |
Primary outcome
Skin lipid profile of acne and healthy patients
Time frame: baseline visit
Compare the skin lipid profile of acne and healthy patients at baseline
1 secondary outcome
Skin lipid profile of acne patients after treatment
Time frame: at 1 month and 4-5 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Background: PubMed 2648418Thody AJ, Shuster S. Control and function of sebaceous glands. Physiol Rev. 1989 Apr;69(2):383-416. doi: 10.1152/physrev.1989.69.2.383.
- Background: PubMed 8369207Blume U, Verschoore M, Poncet M, Czernielewski J, Orfanos CE, Schaefer H. The vellus hair follicle in acne: hair growth and sebum excretion. Br J Dermatol. 1993 Jul;129(1):23-7. doi: 10.1111/j.1365-2133.1993.tb03306.x.
- Background: PubMed 18474083Zouboulis CC, Baron JM, Bohm M, Kippenberger S, Kurzen H, Reichrath J, Thielitz A. Frontiers in sebaceous gland biology and pathology. Exp Dermatol. 2008 Jun;17(6):542-51. doi: 10.1111/j.1600-0625.2008.00725.x.
- Background: PubMed 9248884Doshi A, Zaheer A, Stiller MJ. A comparison of current acne grading systems and proposal of a novel system. Int J Dermatol. 1997 Jun;36(6):416-8. doi: 10.1046/j.1365-4362.1997.00099.x. No abstract available.
- Background: PubMed 131844Morello AM, Downing DT, Strauss JS. Octadecadienoic acids in the skin surface lipids of acne patients and normal subjects. J Invest Dermatol. 1976 May;66(5):319-23. doi: 10.1111/1523-1747.ep12482300.
- University of California-Davis Department of Dermatology Clinical ResearchLink provided by the sponsor.
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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.
Raja K Sivamani, MD principal investigator
UC Davis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne, run by University of California, Davis at 2 sites 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Skin lipid profile of acne and healthy patients (time frame: baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02180425, which also lists 5 linked publications.
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 30 May 2017.