Skip to main content
OpenTrials
Completed

NCT Number: NCT01694433

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

UCLA Dermatology

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Calcipotriene

Drug

1g daily BID

Other names: Dovonex, Vitamin D cream

Placebo

Drug

1g daily BID

Other names: Placebo cream manufactured to mimic calcipotriene

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: Weeks 2, 4, 8 & 12

    Investigator's Global Assessment (IGA) is a 5-point scale of acne severity, ranging from 0 (Clear) to 4 (Severe)

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

Innate Immunity in Acne Vulgaris

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 27, 2012
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.