Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT01694810 |
Recruitment Status :
Completed
First Posted : September 27, 2012
Last Update Posted : October 12, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acne Vulgaris | Drug: 2% NVN1000 Topical Gel Drug: 4% NVN1000 Topical Gel Drug: 8% NVN1000 Topical Gel Drug: Vehicle Topical Gel | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Multiple Dose, Single-Center, Observer-Blind Parallel Group Study Evaluating Safety and Cutaneous Tolerability of NVN1000 Topical Gel in Healthy Volunteers |
Study Start Date : | September 2012 |
Actual Primary Completion Date : | November 2012 |
Actual Study Completion Date : | November 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: 2% NVN1000 Topical Gel
2% NVN1000 Topical Gel once daily for 4 weeks
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Drug: 2% NVN1000 Topical Gel
2% NVN1000 Topical Gel once daily for 4 weeks
Other Name: NVN1000 |
Experimental: 4% NVN1000 Topical Gel
4% NVN1000 4% Topical Gel once daily for 4 weeks
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Drug: 4% NVN1000 Topical Gel
4% NVN 1000 4% Topical Gel applied once daily 4 weeks
Other Name: NVN1000 |
Placebo Comparator: Vehicle Topical Gel
Vehicle Topical Gel once daily for 4 weeks
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Drug: Vehicle Topical Gel
Vehicle Topical Gel applied once daily
Other Name: Vehicle |
Experimental: 8% NVN1000 Topical Gel
8% NVN1000 8% Topical Gel applied once daily for 4 weeks
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Drug: 8% NVN1000 Topical Gel
8% NVN1000 Topical Gel applied once daily for 4 weeks
Other Name: NVN1000 |
- Cutaneous Tolerability [ Time Frame: 4 weeks ]Cutaneous tolerability using a 4 point (0-3) assessment tool
- Safety [ Time Frame: 4 weeks ]Safety assessments include physical examinations with vital signs, laboratory testing
- Change in Microbiology [ Time Frame: baseline and 4 weeks ]P. Acnes counts

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy male and female volunteers
- Age 18 or older
- High degree of fluorescence of facial skin under Wood's lamp
Exclusion Criteria:
- Acute or chronic skin disorders
- Use of topical or systemic antibiotics within 4 weeks of study
- Concomitant use of nitroglycerin or other nitric oxide donor drugs
- Females who are pregnant, planning pregnancy or breast feeding

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694810
United States, Pennsylvania | |
KGL, Inc | |
Broomall, Pennsylvania, United States, 19008 |
Principal Investigator: | James J Leyden, MD | KGL, Inc. |
Responsible Party: | Novan, Inc. |
ClinicalTrials.gov Identifier: | NCT01694810 History of Changes |
Other Study ID Numbers: |
NI-AC002 |
First Posted: | September 27, 2012 Key Record Dates |
Last Update Posted: | October 12, 2018 |
Last Verified: | October 2018 |
acne vulgaris |
Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases |