Phase 3
Completed N=66
"Clinical Trial to Determine the Efficacy of Vitamin D for Acne Therapy"
Source: ClinicalTrials.gov NCT01694433 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Lesion Counts (Total, Inflammatory and Non-inflammatory) — 18.4; 13.4; 15.8; 9.9 Lesions
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lesion Counts (Total, Inflammatory and Non-inflammatory) |
18.4; 13.4; 15.8; 9.9; 12.1; 10.2 | — |
| SECONDARY Acne Severity as Assessed With the Investigator's Global Assessment (IGA) |
2.77; 2.9; 2.83; 2.59; 2.21; 2.48 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01694433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.