CompletedNCT01694433Updated May 7, 2019Results posted

"Clinical Trial to Determine the Efficacy of Vitamin D for Acne Therapy"

A Phase 2/3 interventional study of Calcipotriene and Placebo in Acne Vulgaris, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-07.

Sponsored by University of California, Los Angeles · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 66
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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. 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 studied

Acne Vulgaris

Browse trials for

Acne Vulgaris 750

In context

Acne Vulgaris

750 studies on the registry are indexed under Acne Vulgaris; 89 are open to participants now.

This study's enrollment of 66 is close to the median of 69 across 647 interventional studies indexed under Acne Vulgaris.

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Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,167 studies on the registry; 192 are open to participants now.

Of its 94 completed or terminated interventional studies of FDA-regulated products, 69 (73%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single group
Masking: Double (Participant, Investigator)
Enrollment: 66 participants (actual)

Study arms

Experimental
Calcipotriene Cream
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.
Drug: Calcipotriene
Placebo comparator
Placebo
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.
Drug: Placebo

Interventions

DrugCalcipotriene
1g daily BID
Also known as: Dovonex, Vitamin D cream
DrugPlacebo
1g daily BID
Also known as: Placebo cream manufactured to mimic calcipotriene

What researchers measure

Primary outcomes

Lesion Counts (Total, Inflammatory and Non-inflammatory)
Lesion counts will be assessed by one of the investigator physicians or nurse practitioner.
Time frame: Weeks 2, 4, 8 & 12

Secondary outcomes

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)
Time frame: Weeks 2, 4, 8 & 12

Results

Posted May 7, 2019

Participant flow

Participant flow — Overall Study
Milestone	Calcipotriene Cream	Placebo
Started	33	33
Baseline visit	33	32
Completed	22	29
Not completed	11	4
Withdrew: Adverse event	7	0
Withdrew: Physician decision	1	0
Withdrew: Withdrawal by subject	3	4

Outcome measures

PrimaryLesion Counts (Total, Inflammatory and Non-inflammatory)

Lesion counts will be assessed by one of the investigator physicians or nurse practitioner.

Time frame:: Weeks 2, 4, 8 & 12
Reported as:: Mean · Lesions

Lesion Counts (Total, Inflammatory and Non-inflammatory)
Lesions	Calcipotriene Cream	Placebo
Inflammatory lesions at Week 2	18.4 (1 to 89)	13.4 (0 to 66)
Inflammatory lesions at Week 4	15.8 (0 to 66)	9.9 (1 to 34)
Inflammatory lesions at Week 8	12.1 (0 to 94)	10.2 (0 to 31)
Inflammatory lesions at Week 12	10.5 (0 to 37)	7.0 (0 to 43)
Non-inflammatory lesions at Week 2	30.9 (1 to 152)	33.1 (0 to 131)
Non-inflammatory lesions at Week 4	35.5 (3 to 299)	34.4 (0 to 198)
Non-inflammatory lesions at Week 8	22.1 (0 to 136)	24.3 (0 to 110)
Non-inflammatory lesions at Week 12	19.6 (0 to 78)	20.2 (1 to 60)
Total lesions at Week 2	51.0 (6 to 241)	46.5 (2 to 158)
Total lesions at Week 4	51.4 (0 to 299)	44.3 (2 to 232)
Total lesions at Week 8	34.2 (0 to 136)	34.55 (1 to 134)
Total lesions at Week 12	30.1 (0 to 78)	27.24 (2 to 73)

SecondaryAcne 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)

Time frame:: Weeks 2, 4, 8 & 12
Reported as:: Mean · score on a scale

Acne Severity as Assessed With the Investigator's Global Assessment (IGA)
score on a scale	Calcipotriene Cream	Placebo
IGA at Week 2	2.77 (1 to 4)	2.9 (1 to 4)
IGA at Week 4	2.83 (1 to 4)	2.59 (1 to 4)
IGA at Week 8	2.21 (1 to 4)	2.48 (1 to 4)
IGA at Week 12	2.23 (1 to 4)	2.31 (1 to 4)

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Calcipotriene Cream	0/33 (0%)	0/33 (0%)	18/33 (54.5%)
Placebo	0/32 (0%)	0/32 (0%)	19/32 (59.4%)

Most frequent other events

Showing 10 of 19

Most frequent other events
Event	Calcipotriene Cream	Placebo
Facial drynessSkin and subcutaneous tissue disorders	18/33	5/32
Common cold/allergyInfections and infestations	10/33	7/32
RednessSkin and subcutaneous tissue disorders	7/33	2/32
Facial irritationSkin and subcutaneous tissue disorders	5/33	2/32
AcneSkin and subcutaneous tissue disorders	4/33	2/32
InfectionInfections and infestations	0/33	2/32
Flu-like symptomsGeneral disorders	1/33	2/32
HeadacheGeneral disorders	0/33	2/32
ItchingSkin and subcutaneous tissue disorders	1/33	2/32
RashSkin and subcutaneous tissue disorders	1/33	2/32

Baseline characteristics

One enrolled participant withdrew from the Placebo arm prior to Baseline

Age, Categorical
Age, Categorical(Participants)	Calcipotriene Cream	Placebo	Total
<=18 years	0	0	0
Between 18 and 65 years	33	32	65
>=65 years	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Calcipotriene Cream	Placebo	Total
Female	22	22	44
Male	11	10	21

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Calcipotriene Cream	Placebo	Total
Hispanic or Latino	6	8	14
Not Hispanic or Latino	27	24	51
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Calcipotriene Cream	Placebo	Total
American Indian or Alaska Native	0	0	0
Asian	13	15	28
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	2	1	3
White	18	16	34
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Calcipotriene Cream	Placebo	Total
United States	33	32	65

Inflammatory Lesion Count
Inflammatory Lesion Count(Lesions)	Calcipotriene Cream	Placebo	Total
Mean	16.8 (0 to 59)	11.7 (1 to 34)	14.3 (1 to 59)

Non-inflammatory Lesion Count
Non-inflammatory Lesion Count(Lesions)	Calcipotriene Cream	Placebo	Total
Mean	48.4 (4 to 440)	38.4 (2 to 141)	43.5 (4 to 440)

Total Lesion Count
Total Lesion Count(Lesions)	Calcipotriene Cream	Placebo	Total
Mean	67.3 (13 to 452)	50.1 (5 to 146)	57.8 (5 to 452)

1 further baseline measures are reported on the registry.

Study locations

1 site

UCLA Dermatology
Los Angeles, California 90095, United States

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2013, a primary completion of Jan 2014 and a completion of Jan 2014. It does not say whether these dates are actual or estimated.

Results were first posted in May 2019, 5 years 3 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 24, 2012
First posted: Sep 27, 2012
Start: Feb 2013
Primary completionActual: Jan 9, 2014
CompletionActual: Jan 9, 2014
Results first posted: May 7, 2019
Last update: May 7, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01694433
Lead sponsor: University of California, Los Angeles
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Responsible party: Jenny Kim, MD, PhD (Professor of Medicine/Dermatology, University of California, Los Angeles) — Principal investigator
First posted: Sep 27, 2012
Start date: Feb 2013
Primary completion: Jan 9, 2014
Completion: Jan 9, 2014
Results posted: May 7, 2019
Last update: May 7, 2019

Study contacts

Jenny Kim, MD,PhD

principal investigator · UCLA Department of Medicine/Division of Dermatology and Nutrition

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes

View the source record on ClinicalTrials.gov ↗

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