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.

INTERVENTION: 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 Concentration type: equal Trade Name: Volon A 10 Pharmaceutical Form: Solution for injection INN or Proposed INN: Triamcinolonacetonide CAS Number: 76‐25‐5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal CONDITION: Keloid ; MedDRA version: 8.1 Level: LLT Classification code 10023330 Term: Keloid scar PRIMARY OUTCOME: 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. Primary end point(s): Clinical appearance: score values (sum) of the "Modified Vancouver Scar Scale (MVSS)" 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. 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