E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023330 |
E.1.2 | Term | Keloid scar |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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)
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical appearance: score values (sum) of the "Modified Vancouver Scar Scale (MVSS)" |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 24 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |