Track topics on Twitter Track topics that are important to you
This is a Phase 2a study which is being conducted in healthy volunteers in order to evaluate the comparative reduction of Propionibacterium acnes in-vivo following once daily topical administration of BPX-01 Minocycline 1% Topical Gel (BPX-01) or BPX-01 Vehicle control.
The objective of this study is to evaluate the comparative reduction of Propionibacterium acnes (P. acnes) in-vivo following once daily topical administration of BPX-01 Minocycline 1% Topical Gel or BPX-01 Vehicle control Gel.
A secondary objective is to assess the tolerance of the treatment regimen versus a vehicle control. Safety laboratory data (chemistry and hematology) and plasma levels of minocycline are also of significant interest to the sponsor.
This is a single center, randomized, double blind, two-cell, vehicle controlled P. acnes study. All subjects will be randomized 2:1 to 1% BPX-01 or vehicle control to be applied as a topical gel once daily for four (4) weeks.
This is a six (6) week study with a four (4) week treatment period and a two (2) week post treatment follow up visit. The clinical endpoint is in-vivo quantification of P.acnes. The safety/tolerance endpoints are; observer reported: erythema, scaling-peeling, edema, and subject reported: tightness, burning-stinging, and itching. Plasma levels of minocycline and basic hematology and chemistry laboratory values will be collected.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
BPX-01, 1% Topical Gel, BPX-01 Vehicle Gel
KGL Skin Study Center
Not yet recruiting
Published on BioPortfolio: 2016-03-16T04:08:22-0400
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Dose-ranging Study in the Treatment of Acne Vulgaris,
UHE-101 cream, 1% ("UHE-101") is being developed for the topical treatment of acne vulgaris. The purpose of this study is to compare the safety and efficacy of twice daily topical applicat...
This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety ...
The primary objective of this study is to evaluate the safety and efficacy of Omiganan (CLS001) topical gel compared to vehicle topical gel applied once daily for 12 weeks in female subjec...
The objective of the study is to evaluate the safety, tolerability, and therapeutic equivalence of GDC 268 to Clindamycin Phosphate Topical Lotion, 1% and to compare the efficacy of these ...
Acne vulgaris, a common and chronic disorder of the pilosebaceous unit, affects up to 85% of adolescent and young adults. Although the current treatment options are effective, they are associated with...
Acne vulgaris is a common disease which affects about 85% of the population. Various topical drugs are available, but the retinoid derivatives are mostly taken into consideration. They are used as a f...
The psychological factors associated with the impairment of the quality of life (QoL) in acne vulgaris have not been fully elucidated, yet. The aim of the present study was to evaluate the performance...
Staphylococcus epidermidis is a bacterium known to inhabit the skin. In treatment of acne vulgaris, the cutaneous milieu is exposed to oral or topical antimicrobials. We previously reported that the a...
Acne vulgaris (acne) presents with increased oil-sebum secretion and subsequent formation of comedones, papules, pustules and nodules. Skin cleansing is part of the daily routine to improve skin condi...
A topical dermatologic agent that is used in the treatment of ACNE VULGARIS and several other skin diseases. The drug has teratogenic and other adverse effects.
A chronic disorder of the pilosebaceous apparatus associated with an increase in sebum secretion. It is characterized by open comedones (blackheads), closed comedones (whiteheads), and pustular nodules. The cause is unknown, but heredity and age are predisposing factors.
A progesterone that has been used in ESTRUS SYNCHRONIZATION and has been evaluated as an injectable contraceptive in combination with estradiol enanthate. It is also used therapeutically as a topical anti-inflammatory and is applied topically in the treatment of ACNE.
Severe and chronic form of acne characterized by large, burrowing abscesses associated with disfigurement.
Visible efflorescent lesions of the skin caused by acne or resembling acne. (Dorland, 28th ed, p18, 575)
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells. In vertebrates, it is composed of blo...