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.

• Conditions: Keloid; MedDRA version: 8.1Level: LLTClassification code 10023330Term: Keloid scar

• Registration Number: EUCTR2006-002003-14-DE
• Lead Sponsor: Winthrop Arzneimittel GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified