EUCTR2022-003070-23-GR进行中（未招募）1 期
A multicenter, randomized, double-blind, parallel, three-arm, active- and placebo-controlled therapeutic equivalence for the comparison of clindamycin + tretinoin/Verisfield gel (1+0.025)% with Acnatac®/Meda gel [clindamycin + tretinoin (1+0.025)%] in the treatment of acne vulgaris
Verisfield S.M.S.A.0 个研究点开始时间: 2022年12月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or non-pregnant non-lactating female aged = 12 and = 40 years at the time of consent/assent.
- •Subject has a clinical diagnosis of mild to severe facial acne vulgaris defined as Grade 2, 3, or 4 based on the IGA at Baseline.
- •Subject must have = 25 non-inflammatory lesions (i.e., open and closed comedones) AND = 20 inflammatory lesions (i.e., papules and pustules) AND = 2 nodulocystic lesions (i.e., nodules and cysts) on the face at Baseline.
- •Subject has used the same type and brand of non-medicated make-up, cleanser or other non-medicated facial products and hair products for at least 14 days prior to Baseline and agrees to continue and not change his/her non-facial general skin care and hair care products and frequency of use for the entire study period.
- •Subject must be willing and able to refrain from use of all other topical products applied to face (moisturizer, new brands of make-up, creams, lotions, powders or any topical product other than the assigned treatment to the treatment area and the study-supplied cleanser and sunscreen), all acne medications and antibiotics for acne present on the face during the 12-week treatment period.
- •Subject, in the Investigator’s opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of facial acne vulgaris or otherwise impact the integrity of the study, or exposes the subject to an unacceptable risk by study participation.
- •If FOCBP1,2, willingness to use an acceptable form of birth control during the study [i.e., must have been using accepted methods of birth control or must agree to continue to practice abstinence, from 30 days prior to study entry to 30 days after the last administration of the IP]. FOCBP must have a negative urine pregnancy test (UPT)3 at Baseline.
- •Subject and parent(s)/guardian (if applicable) are willing and able to apply the IP as directed, comprehend and comply with study instructions, and follow the requirements of the study (including availability on scheduled visit dates) for the duration of the study.
- •Subject [and their parents(s)/guardian/legally authorized representative(s), as applicable] is (are) able to understand and willing to provide voluntary written informed assent/consent before any study-related procedure is performed.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 500
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subject is pregnant, breastfeeding or is planning a pregnancy or breastfeed throughout the study period and for 30 days after the last administration of the IP.
- •Subject has pustular and deep cystic nodular acne varieties (acne conglobata and acne fulminans), or other forms of acne (e.g., acne mechanica).
- •Subject has Crohn’s disease, regional enteritis, ulcerative colitis or history of antibiotic-associated colitis.
- •Subject has atopic dermatitis or a history of acute eczemas, rosacea and perioral dermatitis, and any skin condition that, in the Investigator’s opinion, could interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
- •Subject has a personal history of skin cancer.
- •Excessive facial hair (e.g. beards, sideburns, moustaches, etc.), facial tattoos, or other facial attributes that could interfere, in the Investigator’s opinion, with diagnosis or assessment of acne vulgaris.
- •Subject has any contraindication to clindamycin phosphate and tretinoin or history of hypersensitivity or allergy to tretinoin, retinoids, clindamycin or to any of the study medication excipients or lincomycin (see section 11.1).
- •Subject has used for less than 3 months (90 days) prior to Baseline oestrogens or oral contraceptives; subjects treated with such agents 30 or more consecutive dates immediately prior to Baseline need not be excluded unless the subject expects to change dose, drug or discontinue this use during the study. If the subject had used hormonal birth control and had stopped, this should have occurred more than 3 months prior to Baseline.
- •Subject has used antipruritics, including antihistamines within 24 hours prior to Baseline.
- •Subject has used any of the following topical preparations or procedures on the face:
- •- within 1 month (30 days) prior to Baseline:
- •a. cryodestruction or chemodestruction
- •b. dermabrasion
- •c. photodynamic therapy including other light-based and laser therapies
- •d.acne surgery
- •e. intralesional steroids
- •f. x-ray therapy.
- •- within 2 weeks prior to Baseline:
- •a. topical steroids
- •b. topical retinoids (e.g., tazarotene, adapalene, and tretinoin)
- •c. topical acne treatments including, but not limited to, OTC acne cleansers, soaps, washes or treatments, benzoyl peroxide, antibiotics, azelaic acid, dapsone, sulfa based products, corticosteroids, and salicylic acid
- •d. topical anti-inflammatory agents
- •e. topical antibiotics
- •- at any time prior to Baseline:
- •a. other topical therapy which may materially affect the subject’s acne, in the Investigator’s opinion.
- •Subject has used any of the following systemic medication:
- •- within 6 months prior to Baseline:
- •a. oral retinoids (e.g., Accutane®)
- •b. therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
- •- within 3 months prior to Baseline:
- •a. hormonal therapy for acne management
- •- within 1 month prior to Baseline:
- •a. androgen receptor blockers (e.g., spironolactone, flutamide)
- •b. steroids (including intramuscular, intra-articular, and intralesional injections)
- •c. antibiotics
- •d. treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout)
- •e. anti-inflammatory agents
- •f. immunosuppressive drugs.
- •- within 2 weeks prior to Baseline:
- •a. neuromuscular blocking agents such as botulinum toxin type A (e.g.,
研究者
相似试验
进行中（未招募）
1 期
Study to evaluate the efficacy and safety of P-3058 10% solution in the treatment of nails affected by fungiEUCTR2015-000561-31-GRPolichem S.A.840
尚未招募
1 期
To evaluate action and saety of test product Benzoyl peroxide and Clindamycin Phosphate gel with Reference Product BenzaClin Topical gel in treatment of patients with medium to high acne vulgaris.CTRI/2017/09/009884Alvogen Pine Brook LLC
进行中（未招募）
1 期
A double-blind, randomized, parallel, multicenter, vehicle-controlled, left/right paired comparison to study the efficacy, safety and tolerability of 1% LAS 37779 cream administered once and twice daily topically during 4 weeks in patients with chronic plaque psoriasis.EUCTR2005-003162-42-DEAlmirall Prodesfarma S.A.
进行中（未招募）
不适用
A multicentre, double-blind, parallel, randomized, placebo-controlled study Evaluation of the efficacy and safety of Levocetirizine 5 mg and Desloratadine 5 mg administered orally as capsules once daily, in the morning, over 2 weeks in patients suffering from Allergic Rhinitis ARRespiratory AllergyMedDRA version: 6.1Level: PTClassification code 10039085EUCTR2004-002823-42-ITCB PHARMA729
进行中（未招募）
不适用
A multicentre, double-blind, parallel, randomized, placebo-controlled study :Evaluation of the efficacy and safety of Levocetirizine 5 mg and Desloratadine 5 mgadministered orally as capsules once daily, in the morning, over 2 weeks in patientssuffering from Seasonal Allergic Rhinitis (SAR) due to grass polleAllergic Rhinitis (AR)MedDRA version: 7.1Level: LLTClassification code 10001723EUCTR2004-002823-42-DECB S.A. Pharma Sector729