NL-OMON40605招募中4 期
Treatment of port wine stains using Pulsed Dye Laser, Erbium Yag Laser and topical sirolimus in an open label pilot study (POLAR). - Acroniem: POLAR trial. Verkorte titel: New treatment for port wine stains
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 20
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Subject has provided informed consent;
- •Subject is >= 18 years of age at time of screening;
- •Subject has an extra-facial homogenous PWS;
- •The PWS is large enough in size to fit one of the templates (at least 11 cm x 3 cm or 7 cm x 5 cm);
- •Subject has not received any laser treatment of the PWS in the last 3 months (in the treatment area);
- •The PWS has a minimal erythema grading score of 3 (on a 4 point scale) in the opinion of the investigator;
- •Screening blood safety values are within normal parameters or regarded as not clinically significant in the opinion of the investigator.
排除标准
- •PWS with a nodular/hypertrophic component in the treatment area;
- •PWS on cosmetically unacceptable locations in the opinion of the investigator;
- •For women: pregnant or breast feeding during the treatment period;
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using adequate contraceptive measures; Effective contraception is defined as either:
- •o Barrier method of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicide.
- •The following methods are considered more effective than the barrier method and are also acceptable:
- •o Total abstinence (when this is in line with the preferred and usual lifestyle of the subject).
- •o Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before participating in the study.
- •o Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject.
- •o Use of oral, injected or implanted hormonal methods of contraception or other forms, intrauterine device (IUD) or intrauterine system (IUS)
- •NOTE: Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago.
- •Subject is known to have immune deficiency, or is immune compromised (including immunosuppression induced by medication);
- •Known allergy to sirolimus or other constituents of the study medication;
- •Incapacitated subjects;
- •Any medical or psychiatric condition which, in the investigator*s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
研究者
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