Acne Vulgaris
Conditions
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.
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.
Interventions
DRUGCalcipotriene
1g daily BID
DRUGPlacebo
1g daily BID
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age 18 years or older, of either gender and any racial/ethnic group 2. Subjects must have clinically evident mild to moderate acne vulgaris of the facial area, IGA scale, grade 2-4 3. Subjects must understand and sign the informed consent prior to participation 4. Subjects must be in generally good health 5. Subjects must be able and willing to comply with the requirements of the protocol
Exclusion criteria
1. Oral retinoid use within twelve months of entry into the study 2. Systemic acne therapies (oral antibiotics) within 30 days of entry into the study 3. Topical acne therapies (retinoids, antibiotics) within 14 days of entry into the study 4. Non-compliant patients 5. Pregnant or nursing women 6. Subjects with a significant medical history or concurrent condition that the investigator(s) feel is not safe for study participation 7. Subjects with hypercalcemia (hyperparathyroidism, kidney disease) 8. Subjects who cannot avoid excessive exposure to either natural or artificial sunlight.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lesion Counts (Total, Inflammatory and Non-inflammatory) | Weeks 2, 4, 8 & 12 | Lesion counts will be assessed by one of the investigator physicians or nurse practitioner. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acne Severity as Assessed With the Investigator's Global Assessment (IGA) | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Calcipotriene Cream The Calcipotriene Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks.
Calcipotriene: 1g daily BID | 33 |
| Placebo The Placebo Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks.
Placebo: 1g daily BID | 32 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Calcipotriene Cream | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 32 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 8 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 24 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| IGA at Baseline | 3.15 score on a scale | 3.06 score on a scale | 3.11 score on a scale |
| Inflammatory Lesion Count | 16.8 Lesions | 11.7 Lesions | 14.3 Lesions |
| Non-inflammatory Lesion Count | 48.4 Lesions | 38.4 Lesions | 43.5 Lesions |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 15 Participants | 28 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 16 Participants | 34 Participants |
| Region of Enrollment United States | 33 participants | 32 participants | 65 participants |
| Sex: Female, Male Female | 22 Participants | 22 Participants | 44 Participants |
| Sex: Female, Male Male | 11 Participants | 10 Participants | 21 Participants |
| Total Lesion Count | 67.3 Lesions | 50.1 Lesions | 57.8 Lesions |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 32 |
| other Total, other adverse events | 18 / 33 | 19 / 32 |
| serious Total, serious adverse events | 0 / 33 | 0 / 32 |
Outcome results
Primary
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
Population: The number of participants analyzed differ from overall number analyzed due to participant withdrawal or missed study visit.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Calcipotriene Cream | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Inflammatory lesions at Week 2 | 18.4 Lesions |
| Calcipotriene Cream | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Inflammatory lesions at Week 4 | 15.8 Lesions |
| Calcipotriene Cream | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Inflammatory lesions at Week 8 | 12.1 Lesions |
| Calcipotriene Cream | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Inflammatory lesions at Week 12 | 10.5 Lesions |
| Calcipotriene Cream | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Non-inflammatory lesions at Week 2 | 30.9 Lesions |
| Calcipotriene Cream | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Non-inflammatory lesions at Week 4 | 35.5 Lesions |
| Calcipotriene Cream | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Total lesions at Week 12 | 30.1 Lesions |
| Calcipotriene Cream | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Non-inflammatory lesions at Week 8 | 22.1 Lesions |
| Calcipotriene Cream | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Non-inflammatory lesions at Week 12 | 19.6 Lesions |
| Calcipotriene Cream | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Total lesions at Week 2 | 51.0 Lesions |
| Calcipotriene Cream | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Total lesions at Week 4 | 51.4 Lesions |
| Calcipotriene Cream | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Total lesions at Week 8 | 34.2 Lesions |
| Placebo | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Total lesions at Week 8 | 34.55 Lesions |
| Placebo | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Inflammatory lesions at Week 2 | 13.4 Lesions |
| Placebo | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Non-inflammatory lesions at Week 12 | 20.2 Lesions |
| Placebo | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Inflammatory lesions at Week 4 | 9.9 Lesions |
| Placebo | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Total lesions at Week 12 | 27.24 Lesions |
| Placebo | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Inflammatory lesions at Week 8 | 10.2 Lesions |
| Placebo | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Total lesions at Week 4 | 44.3 Lesions |
| Placebo | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Inflammatory lesions at Week 12 | 7.0 Lesions |
| Placebo | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Non-inflammatory lesions at Week 8 | 24.3 Lesions |
| Placebo | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Non-inflammatory lesions at Week 2 | 33.1 Lesions |
| Placebo | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Total lesions at Week 2 | 46.5 Lesions |
| Placebo | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Non-inflammatory lesions at Week 4 | 34.4 Lesions |
Secondary
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
Population: The number of participants analyzed differ from overall number analyzed due to participant withdrawal or missed study visit.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Calcipotriene Cream | Acne Severity as Assessed With the Investigator's Global Assessment (IGA) | IGA at Week 2 | 2.77 score on a scale |
| Calcipotriene Cream | Acne Severity as Assessed With the Investigator's Global Assessment (IGA) | IGA at Week 4 | 2.83 score on a scale |
| Calcipotriene Cream | Acne Severity as Assessed With the Investigator's Global Assessment (IGA) | IGA at Week 8 | 2.21 score on a scale |
| Calcipotriene Cream | Acne Severity as Assessed With the Investigator's Global Assessment (IGA) | IGA at Week 12 | 2.23 score on a scale |
| Placebo | Acne Severity as Assessed With the Investigator's Global Assessment (IGA) | IGA at Week 12 | 2.31 score on a scale |
| Placebo | Acne Severity as Assessed With the Investigator's Global Assessment (IGA) | IGA at Week 2 | 2.9 score on a scale |
| Placebo | Acne Severity as Assessed With the Investigator's Global Assessment (IGA) | IGA at Week 8 | 2.48 score on a scale |
| Placebo | Acne Severity as Assessed With the Investigator's Global Assessment (IGA) | IGA at Week 4 | 2.59 score on a scale |