EUCTR2006-002003-14-DE进行中（未招募）不适用
Efficacy and tolerability of Triamcinolonacetonide crystalline solution for local treatment of keloids: clinical verum-controlled study in parallel groups with Triam 10 mg Lichtenstein versus Volon A 10.Prospective, double-blind, randomised, clinical multicentre Phase IV study with two treatment groups.Study title in German (see study protocol) Wirksamkeit und Verträglichkeit von Triamcinolonacetonid Kristallsuspension zur lokalen Behandlung von Keloiden: klinischer Verum-kontrollierter Parallelvergleich von Triam 10 mg Lichtenstein versus Volon A 10.Prospektive, doppelblinde, randomisierte, klinische Multizenterstudie der Phase IV mit zwei Behandlungsgruppen.
Winthrop Arzneimittel GmbH0 个研究点开始时间: 2006年9月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •1. Females and males aged between 18 and 65 years (Caucasian with pale colour of the skin: sun-reaction reactive skin type I to IV according to Fitzpatrick)
- •2. Signed informed consent form for study participation and data protection
- •3. Keloid - neither in face nor on haired head nor in a joint region - which fulfills the following criteria:
- •- height: between 2 to 7 mm
- •- area: between 1,0 to 10 cm2
- •- existing since at least 2 months but not longer than 2 years
- •- MVSS: a score value of at least 10 whereas the height of the scar is at least 2 mm
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Hypertrophic scar or keloid-like changes (acne keloidalis nuchae, pseudofolliculitis barbae) but no keloid
- •2. Prohibited previous treatments
- •3. Prohibited local or systemic concomitant treatments
- •4. Contraindication to an intralesional application of the study medication:
- •- hypersensitivity to triamcinolonacetonide, benzyl alcohol or other ingredients of
- •Triam 10 mg Lichtenstein or Volon A 10
- •- acute viral infection (herpes zoster, herpes simplex, vricelles, herpetic keratitis)
- •- HBs-antigen positive chronic-active hepatitis
- •- approximately 8 weeks prior to until 2 weeks after vaccination with live vaccine
- •- systemic fungal infections or parasitic diseasess (i.e. nematodes), amebiasis
- •- poliomyelitis
- •- lymphadenitis following BCG-vaccination
- •- perioral dermatitis, rosacea, abscess
- •- acute and chronic bacterial (putride) infections
- •- tuberculosis in medical history (be aware of reactivation) - use of study drug
- •together with tuberculostatic medication, only
- •- tuberculotic or syphilitic skin eruptions
- •- severe osteoporosis
- •- hypertension - hard to stabilize
- •- diabetes mellitus - hard to stabilize
- •- psychiatric disease (also in medical history)
- •- convulsive disease
- •- myasthenia gravis
- •- simple or obstructive glaucoma
- •- corneal ulceration or corneal lesion
- •- ulcer disease
- •- severe ulcerative colitis with impending perforation
- •- diverticulitis
- •- enteranastomosis (in the early postoperative period)
- •5. Values of cortisol clearly above upper limit of normal range
- •6. Women of childbearing potential without adequate contraception
- •7. Pregnancy (planned or already existing) or lactation period
- •8. Severe organic, neurological or psychiatric or dermatologic disease
- •9. Study participants, who do not agree to passing on their pseudonymous data
- •10. Participation in another clinical trial (in parallel or within the last 6 months)
- •11. Patient participated already in this trial
- •12. Known abuse of alcohol or drugs
- •13. Study participants who are unable, to understand the nature, scope and possible impact of the study or who are considered to be non-compliant
- •14. Scheduled removal or vaccation during the course of the study, which which does not allow the patient to meet all visits
- •15. Poor language skills (German spoken and written)
研究者
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