Papulopustular Rosacea Clinical Trial
Official title:
A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Intradermally Administered AIV001 in Subjects With Papulopustular Rosacea
Verified date | May 2022 |
Source | AiViva BioPharma, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the safety, efficacy, and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with rosacea.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 2022 |
Est. primary completion date | July 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Healthy male and/or female subjects between the ages of 18 and 65 year with rosacea, 10 to 30 papules and pustules (at least 5 lesions within the treatment area on each facial side), and < 2 nodules - Presence of moderate to severe persistent erythema - Total body weight >45 kg Exclusion Criteria: - Presence of any skin condition on the face that would interfere with the diagnosis or assessment of rosacea - Extremely dark skin type that would confound the digital analysis of erythema (eg, Fitzpatrick Skin Type 5 or 6) - Excessive facial hair (eg, beards, sideburns, moustaches, etc.), birthmarks, or tattoos that would interfere with diagnosis or assessment of rosacea - Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day. - Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception as outlined in this protocol from at least 14 days prior to start of treatment. - Hypersensitivity or allergy to axitinib or any other component of the study treatment - Use within 6 months prior to baseline and during the study of oral retinoids (eg, Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed). - Use within 6 weeks prior to baseline and during the study of vasodilators or a-adrenergic receptor-blocking agents. - Use within 1 month prior to baseline and during the study of 1) topical retinoids to the face, 2) systemic antibiotics know to have an impact on the severity of facial rosacea (eg, containing tetracycline and its derivatives, erythromycin and its derivatives, sulfamethoxazole, or trimethoprim), 3) systemic corticosteroids, or 4) facial light-based therapies |
Country | Name | City | State |
---|---|---|---|
United States | Cosmetic Laser Dermatology | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
AiViva BioPharma, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of Adverse Events | The occurrence of adverse events will be collected and reported using MedDRA to code. Description, start and end dates, and severity will be recorded. | Day 1 through Day 84 | |
Secondary | Efficacy evaluated by the Investigator using the Investigator Global Assessment Scale | Evaluation of rosacea within the treatment area. 0 = clear (No papules and/or pustules; no or residual erythema; no or mild to moderate telangiectasia), 1 = minimal (Rare papules and/or pustules; residual to mild erythema; mild to moderate telangiectasia), 2 = mild (Few papules and/or pustules; mild erythema; mild to moderate telangiectasia), 3 = mild to moderate (Distinct number of papules and/or pustules; mild to moderate erythema; mild to moderate telangiectasia), 4 = moderate (Pronounced number of papules and/or pustules; moderate erythema; mild to moderate telangiectasia), 5 = moderate to severe (Many papules and/or pustules; occasionally with large inflamed lesions; moderate erythema; moderate degree of telangiectasia), and 6 = severe (Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate or severe erythema; moderate or severe telangiectasia). Scores of 0 or 1 are considered success. | Day 1 through Day 84 | |
Secondary | Efficacy evaluated by the Investigator by performing Inflammatory Lesion Counts | The number of inflammatory lesions is a static measure of the number of papules or pustules present within the treatment area. | Day 1 through 84 | |
Secondary | Evaluation of Erythema and Topography using Standardized Photography | Photographs using standardized equipment will be taken and uploaded onto the vendor's server. The vendor will then use proprietary software to measure the amount of redness and the topography of the lesions within the treatment area. | Day 1 through 84 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03276936 -
A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea
|
Phase 3 | |
Completed |
NCT02601963 -
Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea
|
Phase 2 | |
Completed |
NCT02268474 -
Excel V 532 nm KTP Laser for Treatment of Erythematotelangiectatic Rosacea & Papulopustular Rosacea
|
N/A | |
Completed |
NCT01555463 -
Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea
|
Phase 3 | |
Active, not recruiting |
NCT03667222 -
Topical Minocycline Gel for Inflammatory Lesions of Papulopustular Rosacea
|
Phase 2 | |
Terminated |
NCT03564145 -
A Long-Term Safety Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
|
Phase 3 | |
Completed |
NCT05150587 -
Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea
|
Phase 2 | |
Completed |
NCT03263273 -
Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea
|
Phase 2 | |
Completed |
NCT05343455 -
A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2)
|
Phase 3 | |
Completed |
NCT01784133 -
A Twelve Week Safety and Efficacy Study in Rosacea
|
Phase 2 | |
Completed |
NCT01872715 -
Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea
|
Phase 4 | |
Completed |
NCT05296629 -
A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea.
|
Phase 3 | |
Completed |
NCT05838170 -
Study of TP-04 in Participants With Papulopustular Rosacea
|
Phase 2 | |
Recruiting |
NCT06013371 -
PDE4 Inhibition in Seborrheic Dermatitis and Papulopustular Rosacea
|
Phase 2 | |
Recruiting |
NCT03864978 -
Safety and Efficacy of Rifaximin in Patients With Papulopustular Rosacea and Positive Lactulose Breath Test
|
Phase 2 | |
Completed |
NCT03564119 -
A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea
|
Phase 3 | |
Completed |
NCT03079531 -
Open Label Study to Assess the Effect of Secukinumab in Moderate to Severe Papulopustular Rosacea
|
Phase 1/Phase 2 | |
Completed |
NCT01045551 -
Open Label Pilot Study of Apremilast in Treatment of Rosacea
|
Phase 2 | |
Completed |
NCT03448939 -
A Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
|
Phase 3 | |
Completed |
NCT05675501 -
Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties
|
Phase 1 |