Acne Vulgaris Clinical Trial
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
Verified date | January 2020 |
Source | Novan, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study will assess safety and tolerability of different doses of topical gel containing a new chemical entity, NVN1000, and the vehicle (gel without drug) applied to the face of healthy volunteers with high counts of Propionibacterium acnes. The test product will be applied once daily for 4 weeks. Exploratory measures include whether the topical product decreases the amount of a bacteria associated with acne (P. acnes).
Status | Completed |
Enrollment | 60 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | KGL, Inc | Broomall | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Novan, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cutaneous tolerability Evaluation | Cutaneous tolerability evaluations to include erythema, scaling, dryness, puritus and burning/stinging using a 4-category scale with scores ranging from 0-3 (0=none, 1=mild, 2=moderate, 3 - severe). | 4 weeks | |
Secondary | Safety Assessment | Comparison of adverse events between groups. | 4 weeks | |
Secondary | Safety Assessment | Change from baseline in HCT (L/L) | 4 weeks | |
Secondary | Safety Assessment | Change from baseline in HGB, MCHC (g/L) | 4 weeks | |
Secondary | Safety Assessment | Change from baseline in % methemoglobin (%) | 4 weeks | |
Secondary | Safety Assessment | Change from baseline in % Basophils (%) | 4 weeks | |
Secondary | Safety Assessment | Change from baseline in % Eosinophils (%) | 4 weeks | |
Secondary | Safety Assessment | Change from baseline in % Lymphocytes (%) | 4 weeks | |
Secondary | Safety Assessment | Change from baseline in MCH (pg) | 4 weeks | |
Secondary | Safety Assessment | Change from baseline in MCV, MPV (fL) | 4 weeks | |
Secondary | Safety Assessment | Change from baseline in % Monocytes (%) | 4 weeks | |
Secondary | Safety Assessment | Change from baseline in % Neutrophils (%) | 4 weeks | |
Secondary | Safety Assessment | Change from baseline in Platelet Count, WBC (10 ^ 9/L) | 4 weeks | |
Secondary | Safety Assessment | Change from baseline in % RDW (%) | 4 weeks | |
Secondary | Safety Assessment | Change from baseline in RBC (10 ^ 12/L) | 4 weeks | |
Secondary | Safety Assessment | Change from baseline in Albumin, Protein, Total (g/L) | 4 weeks | |
Secondary | Safety Assessment | Change from baseline in Alkaline Phosphatase, ALT, AST, (U/L) | 4 weeks | |
Secondary | Safety Assessment | Change from baseline in Bicarbonate, Bun, Calcium, Chloride, Glucose, Phosphorus, Potassium, Sodium (mmol/L) | 4 weeks | |
Secondary | Safety Assessment | Change from baseline in Bilirubin Direct, Bilirubin Total, Creatinine (umol/ L) | 4 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04321070 -
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
|
Phase 1 | |
Recruiting |
NCT05755256 -
The Impact of Probiotics on Skin Hydration in Youth With Mild Acne
|
Phase 2 | |
Completed |
NCT05131373 -
Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris
|
Phase 1 | |
Completed |
NCT01445301 -
Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects
|
Phase 3 | |
Completed |
NCT03303170 -
Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris
|
N/A | |
Completed |
NCT04698239 -
Clinical Evaluation of the Safety and Benefits of the Milesman 445 nm Blue Laser on Inflammatory Acne Lesions.
|
N/A | |
Completed |
NCT02886715 -
A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris
|
Phase 3 | |
Terminated |
NCT02924428 -
Venus Versa Diamondpolar Applicator Treatment Followed by AC Dual Applicator Treatment for Facial Acne Vulgaris
|
N/A | |
Not yet recruiting |
NCT02525822 -
Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris
|
Phase 2 | |
Completed |
NCT02709902 -
Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris
|
Phase 1 | |
Not yet recruiting |
NCT02491060 -
A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
|
Phase 3 | |
Not yet recruiting |
NCT02535871 -
A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
|
Phase 3 | |
Completed |
NCT02913001 -
The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne
|
N/A | |
Completed |
NCT02250430 -
A Phase 1 Study Assessing Local Cutaneous Effects of SB204
|
Phase 1 | |
Completed |
NCT01769664 -
A Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to Duac® Topical Gel in the Treatment of Acne Vulgaris
|
Phase 1 | |
Completed |
NCT01727440 -
Identifying the Genetic Predictors of Severe Acne Vulgaris and the Outcome of Oral Isotretinoin Treatment
|
N/A | |
Completed |
NCT01194375 -
A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris
|
Phase 2 | |
Completed |
NCT02524665 -
8 Week Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and MURAD To Treat Acne
|
Phase 4 | |
Completed |
NCT01706250 -
U0289-401: Eight Week, Split-face, Study to Determine and Compare the Efficacy and Tolerability of MAXCLARITY™ II to PROACTIV™
|
Phase 4 | |
Completed |
NCT00991198 -
The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage
|
Phase 2 |