Acne VulgarisPhase 2/3NCT01694433
"Clinical Trial to Determine the Efficacy of Vitamin D for Acne Therapy"
A Phase 2/3 study testing Calcipotriene in people with Acne Vulgaris, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to study the effects of topical Vitamin D cream (Calcipotriene, also known as Dovonex) on acne. The information gained from this study may lead to new treatments for acne. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Calcipotriene
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to 9 Jan 2014
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older, of either gender and any racial/ethnic group
- Subjects must have clinically evident mild to moderate acne vulgaris of the facial area, IGA scale, grade 2-4
- Subjects must understand and sign the informed consent prior to participation
- Subjects must be in generally good health
- Subjects must be able and willing to comply with the requirements of the protocol
Who cannot join
- Oral retinoid use within twelve months of entry into the study
- Systemic acne therapies (oral antibiotics) within 30 days of entry into the study
- Topical acne therapies (retinoids, antibiotics) within 14 days of entry into the study
- Non-compliant patients
- Pregnant or nursing women
- Subjects with a significant medical history or concurrent condition that the investigator(s) feel is not safe for study participation
- Subjects with hypercalcemia (hyperparathyroidism, kidney disease)
- Subjects who cannot avoid excessive exposure to either natural or artificial sunlight.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innate Immunity in Acne Vulgaris
The purpose of this study is to study the effects of topical Vitamin D cream (Calcipotriene, also known as Dovonex) on acne. The information gained from this study may lead to new treatments for acne. In this study, Calcipotriene will be compared with a placebo, a cream that looks like Calcipotriene, but contains no active ingredients.
Read the detailed description
This study will be a randomized, double-blinded, parallel group comparison of calcipotriene vs. placebo cream. Patients with acne will use calcipotriene or placebo cream 2x/day for 12 weeks and will be assessed at weeks 0, 2, 4, 8 and 12. Each group will have 24 subjects as calculated by power analysis. Three additional subjects for each group will be recruited for possible dropouts and total of 27 subjects will be recruited for each group. Primary endpoint (lesion count) and secondary endpoint (IGA- Investigator's Global Assessment) will be determined. Lesion counts will be assessed by one of the investigator physicians or nurse practitioner. Adverse effects including irritation, dry skin, inflammation and worsening of the lesions will be noted at each visit. Photographs will be taken to aid in assessing the clinical changes.
- Conditions
- Acne Vulgaris
- Being tested
- Calcipotriene, 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.
CalcipotrieneDrug
Also called Dovonex, Vitamin D cream
1g daily BID
PlaceboDrug
Also called Placebo cream manufactured to mimic calcipotriene
1g daily BID
| Study group | Role | What they receive |
|---|---|---|
| Calcipotriene Cream | Experimental | The Calcipotriene Cream will be supplied as 1g daily use individual tubes to be used 2x/day (once in the morning and once in the evening) for 12 weeks. Receives: Drug: Calcipotriene |
| Placebo | Placebo comparator | The Placebo Cream will be supplied as 1g daily use individual tubes to be used 2x/day (once in the morning and once in the evening) for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion Counts (Total, Inflammatory and Non-inflammatory)
Lesion counts will be assessed by one of the investigator physicians or nurse practitioner.
Measured: Weeks 2, 4, 8 & 12
Secondary outcomes (1)
Acne Severity as Assessed With the Investigator's Global Assessment (IGA)
Investigator's Global Assessment (IGA) is a 5-point scale of acne severity, ranging from 0 (Clear) to 4 (Severe)
Measured: Weeks 2, 4, 8 & 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startFeb 2013
- Primary completion9 Jan 2014
- Study completion9 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acne VulgarisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Jenny Kim, MD, PhD, University of California, Los Angeles
- Investigators
- Jenny Kim, MD,PhD, Principal investigator, UCLA Department of Medicine/Division of Dermatology and Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694433
- Sponsor's protocol ID
- 1R01AR053542-01A2
- Other IDs
- 1R01AR053542-01A2
- Status last verified
- Apr 2019
- First submitted
- 24 Sep 2012
- Last updated
- 7 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innate Immunity in Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01694433
- Acronym / sponsor ID
- 1R01AR053542-01A2
- Conditions
- Acne Vulgaris
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Feb 2013
- Primary completion
- 9 Jan 2014 (actual)
- Study completion
- 9 Jan 2014 (actual)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Posted 7 May 2019
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 study the effects of topical Vitamin D cream (Calcipotriene, also known as Dovonex) on acne. The information gained from this study may lead to new treatments for acne. In this study, Calcipotriene will be compared with a placebo, a cream that looks like Calcipotriene, but contains no active ingredients.
Detailed description
This study will be a randomized, double-blinded, parallel group comparison of calcipotriene vs. placebo cream. Patients with acne will use calcipotriene or placebo cream 2x/day for 12 weeks and will be assessed at weeks 0, 2, 4, 8 and 12. Each group will have 24 subjects as calculated by power analysis. Three additional subjects for each group will be recruited for possible dropouts and total of 27 subjects will be recruited for each group. Primary endpoint (lesion count) and secondary endpoint (IGA- Investigator's Global Assessment) will be determined. Lesion counts will be assessed by one of the investigator physicians or nurse practitioner. Adverse effects including irritation, dry skin, inflammation and worsening of the lesions will be noted at each visit. Photographs will be taken to aid in assessing the clinical changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcipotriene Cream | Experimental | Drug: CalcipotrieneThe Calcipotriene Cream will be supplied as 1g daily use individual tubes to be used 2x/day (once in the morning and once in the evening) for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboThe Placebo Cream will be supplied as 1g daily use individual tubes to be used 2x/day (once in the morning and once in the evening) for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older, of either gender and any racial/ethnic group
- Subjects must have clinically evident mild to moderate acne vulgaris of the facial area, IGA scale, grade 2-4
- Subjects must understand and sign the informed consent prior to participation
- Subjects must be in generally good health
- Subjects must be able and willing to comply with the requirements of the protocol
Key exclusion criteria (8 listed)
- Oral retinoid use within twelve months of entry into the study
- Systemic acne therapies (oral antibiotics) within 30 days of entry into the study
- Topical acne therapies (retinoids, antibiotics) within 14 days of entry into the study
- Non-compliant patients
- Pregnant or nursing women
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 |
|---|---|---|
| CalcipotrieneAlso: Dovonex, Vitamin D cream1g daily BID | Drug | Calcipotriene Cream |
| PlaceboAlso: Placebo cream manufactured to mimic calcipotriene1g daily BID | Drug | Placebo |
Primary outcome
Lesion Counts (Total, Inflammatory and Non-inflammatory)
Time frame: Weeks 2, 4, 8 & 12
Lesion counts will be assessed by one of the investigator physicians or nurse practitioner.
1 secondary outcome
Acne Severity as Assessed With the Investigator's Global Assessment (IGA)
Time frame: Weeks 2, 4, 8 & 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
Jenny Kim, MD,PhD principal investigator
UCLA Department of Medicine/Division of Dermatology and Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Calcipotriene in people with Acne Vulgaris, 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 5 inclusion and 8 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 7 May 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Yes. Results are posted in the registry (first posted 7 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lesion Counts (Total, Inflammatory and Non-inflammatory) (time frame: Weeks 2, 4, 8 & 12). 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 7 May 2019.