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The use of topical retinoids is a mainstay and basis of early acne treatment to prevent the progression to inflammatory lesions. Post oral isotretinoin, it is not uncommon for non-inflammatory papules and comedones to recur. However, there has been no formal study to look at the prevention of recurrence of these acne lesions post isotretinoin in a long term basis. This may enhance the therapeutic options for post isotretinoin patients in order to prevent recurrence of their disease.
Hypothesis Tretinoin microsphere 0.04% will prevent recurrence of acne lesions.
Subjects will be randomized 1:1 to study product or vehicle. Subjects will be randomly assigned to each group by an unblinded dispenser.
The study duration will be 24 weeks with visits at baseline (week 0), week 4, week 8, week 16 and week 24. All study products will be administered once daily for 24 weeks. Subjects will apply a sufficient amount of study product to cover the entire face.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
tretinoin microsphere 0.04% gel, vehicle gel
Active, not recruiting
Published on BioPortfolio: 2014-08-27T03:20:47-0400
The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.
The purpose of this study is to demonstrate the safety and effectiveness of W0265 gel in subjects with acne vulgaris. The hypothesis is that W0265 is superior to Clindamycin Gel, Tretinoin...
Bioequivalence study comparing Tretinoin Cream, 0.05% to RETIN-A®.
Bioequivalence study comparing Tretinoin Cream, 0.1% to RETIN-A®.
The use of oral antibiotics alone to treat inflammatory acne provides little to no long term therapeutic benefit. Acne relapse rates can be reduced by using topical tretinoin 0.01% in con...
BACKGROUND: While it is generally considered to be a disease of adolescence, acne affects an increasing number of adults, especially women. Although data exist on the use of retinoids in adult females...
Drug development continues to focus on the challenge of treating acne effectively and safely. Inflammation is a backdrop to the commonly cited elements of the pathophysiology of acne: Propionibacteriu...
BACKGROUND: Tazarotene has been extensively studied in clinical trials and is widely used to treat acne vulgaris (acne), with data suggesting that is one of the most potent topical retinoids. Irritati...
Acne vulgaris is the most common dermatological disorder globally.1,2 Psychological and emotional distress due to acne, including poor self-esteem, social anxiety, depression, and suicidal ideation ha...
Acne fulminans (AF) is a rare and severe form of inflammatory acne. It is characterized by a sudden worsening of acne with appearance of ulcero-necrotic lesions, which can be associated with systemic ...
An important regulator of GENE EXPRESSION during growth and development, and in NEOPLASMS. Tretinoin, also known as retinoic acid and derived from maternal VITAMIN A, is essential for normal GROWTH; and EMBRYONIC DEVELOPMENT. An excess of tretinoin can be teratogenic. It is used in the treatment of PSORIASIS; ACNE VULGARIS; and several other SKIN DISEASES. It has also been approved for use in promyelocytic leukemia (LEUKEMIA, PROMYELOCYTIC, ACUTE).
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)
A vehicle equipped for transporting patients in need of emergency care.
A naphthalene derivative that has specificity for RETINOIC ACID RECEPTORS. It is used as a DERMATOLOGIC AGENT for the treatment of ACNE.
Acne is a common skin condition that causes spots to develop on the skin, usually on the face, back and chest.. The spots can range from blackheads and whiteheads which are often mild, to inflamed pus-filled pustules and cysts, which can be severe ...