CTRI/2017/02/007835进行中（未招募）3 期
A Comparative, Randomized, Two Arm, Multicentric, Active Controlled, Open label, Parallel Group, Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Ivermectin Cream 1% w/w Vs. Azelaic Acid Gel 15% w/w in Patients with Inflammatory Lesions of Rosacea.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- •2. Patients diagnosed with inflammatory lesions of papulopustular rosacea only in central area of the face, T zone and chin with a score of 2 - 4 according to Investigator Global Assessment (IGA).
- •3. Subjects who would be able to follow the protocol schedules.
- •4. Free of any clinically significant disease which can potentially interfere with the study.
排除标准
- •1.Subjects known to be non-responders to Azelaic Acid.
- •2.Subjects with any bleeding disorders.
- •3.Subjects with comedogenic and non comedogenic papules and pustules of acne vulgaris.
- •4.Subjects with particular forms of rosacea (rosacea conglobate, rosacea fulminant, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis or seborrheic dermatitis and acne.
- •5.Subjects with rosacea with more than two nodules on the face.
- •6.Subjects on treatment of Oral Isotretinoin within 6 months.
- •7.History of any skin diseases and/or ongoing treatment for any other skin related disorder.
- •8.Any acute and/or chronic systemic disorders which is uncontrolled within last one month (cardiovascular, renal, hepatic, respiratory, gastrointestinal, central nervous system, endocrine).
- •9.Pregnant or nursing (lactating) women or women with child bearing potential who are not taking acceptable form of contraceptive.
- •10.Known or suspected hypersensitivity to any drug that will be administered during the study.
- •11.Inability to comply with the protocol requirements.
- •12.Participation in any other clinical trial within 3 months of registering in this trial.
- •13.Medical history of oncological disease within 5 years before screening.
- •14.Patients with infections of HIV, hepatitis B or C.
- •15.Patients with history of wasting disease, autoimmune disease, connective tissue disease or History of drug or alcohol abuse within the previous 2 years.
- •16.Any condition or therapy that in the opinion of the Investigator may pose a risk to the subject or interfere with the evaluation of the study.
研究者
相似试验
已完成
2 期
Evaluation of efficacy of PS/MAR/HO-1 oil and a marketed formulation in mild to moderate Hair loss in femalesCTRI/2015/12/006462Marico Ltd
已完成
3 期
Comparing the treatments of Two Different Lipid preparations of Amphotericin B for the treatment of Kala AzarCTRI/2009/091/000058Bharat Serums and Vaccines Ltd500
已完成
3 期
A Clinical trial to check the effect, Safety and Tolerability of Ripasudil Hydrochloride Hydrate Eye Drops 0.4% w/v Vs Timolol Maleate Eye Drops 0.5% w/v in patients with Ocular Hypertension / GlaucomaCTRI/2018/04/013091Ajanta Pharma Ltd217
已完成
3 期
A study of Netarsudil Ophthalmic Solution 0.02% w/v Vs Timolol Maleate Eye Drops 0.5% w/v in treatment of elevated intraocular pressure in patient with open angle glaucoma or ocular hypertension.CTRI/2020/01/022619Ajanta Pharma Ltd197
进行中（未招募）
不适用
A Multi-Center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients withUntreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg of Ipilimumab (MDX-010) vs. Dacarbazine With Placebo.Revised Protocol 04, incorporating Administrative Letter 01, Administrative Letter 02, Administrative Letter 03, Amendment 02, Amendment 06 and Amendment 07.Stage III (Unresectable) or IV MelanomaEUCTR2005-006082-14-ATBristol-Myers Squibb International Corporation500