Keloid MedDRA version: 8.1 Level: LLT Classification code 10023330 Term: Keloid scar
Conditions
Interventions
Trade Name: Triam 10 mg Lichtenstein
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Triamcinolonacetonide
CAS Number: 76-25-5
Concentration unit: mg/ml milligram(s)/millilitre
Concen
Sponsors
Winthrop Arzneimittel GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to confirm efficacy of intralesional administered Triam 10 mg Lichtenstein versus an in this indication (keloid) licensed comparator (Volon A 10) with the same active component.;Secondary Objective: The secondary objective of this clinical trial is to conform the local tolerability and the systemic safety of - as ist is standard practice - 3 intralesional applications of Triam 10 mg Lichtenstein compared to the reference preparation Volon A 10 in keloids over a period of 2 months.;Primary end point(s): Clinical appearance: score values (sum) of the "Modified Vancouver Scar Scale (MVSS)" | — |
Countries
Germany
Outcome results
None listed