NCT01694433

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2014

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

May 7, 2019

Completed
Last Updated

May 7, 2019

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

September 24, 2012

Results QC Date

March 15, 2019

Last Update Submit

April 18, 2019

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

  • Lesion Counts (Total, Inflammatory and Non-inflammatory)

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

    Weeks 2, 4, 8 & 12

Secondary Outcomes (1)

  • Acne Severity as Assessed With the Investigator's Global Assessment (IGA)

    Weeks 2, 4, 8 & 12

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

CalcipotrieneDRUG

1g daily BID

Also known as: Dovonex, Vitamin D cream
Calcipotriene Cream
PlaceboDRUG

1g daily BID

Also known as: Placebo cream manufactured to mimic calcipotriene
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Dermatology

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

calcipotriene

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Results Point of Contact

Title
Dr. Jenny Kim
Organization
UCLA
jekim@mednet.ucla.edu
310-825-5420

Study Officials

  • Jenny Kim, MD,PhD

    UCLA Department of Medicine/Division of Dermatology and Nutrition

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine/Dermatology

Study Record Dates

First Submitted

September 24, 2012

First Posted

September 27, 2012

Study Start

February 1, 2013

Primary Completion

January 9, 2014

Study Completion

January 9, 2014

Last Updated

May 7, 2019

Results First Posted

May 7, 2019

Record last verified: 2019-04

Locations

US(1)