Clinical trial of "line extension" of drug ARAFARMADOL® 0.075% cream in a new formulation in topical solution applicable in roll-on and with the same therapeutic indications approved for the cream.
The sponsor created a new pharmaceutical formulation of CAPSAICIN topical solution applicable in roll-on. This new formulation in roll-on represents a line extension of drug ARAFARMADOL 0.075 cream, which is currently marketed in Spain by the sponsor. The proposed investigational product as topical solution applicable in roll-on is expected to solve the compliance and safety issues of the cream with the same indications for use. Eligible patients will be randomized into two groups: CAPSAICIN topical solution applicable in roll-on and CAPSAICIN cream (ARAFARMADOL® ) for 8 weeks. Then, they will have a 4 week washout period and will be crossed over to the other treatment group for 8 weeks. A follow-up period of 2 weeks will take place after the end of both treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
161
To demonstrate the efficacy and the non-inferiority of a new formulation of the capsaicin topical solution in "roll-on" compared to capsaicin in cream.
To demonstrate the efficacy and the non-inferiority of a new formulation of Capsaicin 0.75 mg / g topical solution applicable in "roll-on" compared to the formulation currently marketed (comparator) in cream (Arafarmadol® 0.075% cream). The main variable will be the decrease in pain on the visual analogue pain scale (score range from 0 (no pain) to 10 (worst pain possible) at 8 weeks of treatment with each drug. The change in efficacy between the two treatments (pain reduction with cream minus pain reduction with roll-on) will be calculated and the 95% confidence interval for this change will be obtained; If the confidence interval does not exceed the non-inferiority limit (1.0), it will be concluded that the new formulation is not inferior to the one currently marketed.
Time frame: Baseline to 8 weeks
Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) between both treatment groups.
All AEs will be recorded, whether considered minor or serious, drug-related or not.
Time frame: From Visit 1, and at each visit, up to 22 weeks.
Change from baseline in both treatment groups of QoL.
The EQ-5D consists of 2 parts - the descriptive part and the visual scale analog (EVA). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, habitual activities, pain / discomfort, and anxiety / depression. In the EVA the patient scores their health between two extremes, 0 and 100, worst and best health status imaginable.
Time frame: Baseline to 8 weeks
Treatment compliance in both treatment groups.
Treatment compliance is measured by the use of Morisky-Green test.
Time frame: At the end of each treatment phase (8th week).
Change from baseline in both treatment groups of height.
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Height measured by cm.
Time frame: Baseline to every 4 weeks up to 22 weeks.
Change from baseline in both treatment groups of weight.
Weight measured by kg.
Time frame: Baseline to every 4 weeks up to 22 weeks.
Change from baseline in both treatment groups of blood pressure.
Blood pressure measured by mm Hg.
Time frame: Baseline to every 4 weeks up to 22 weeks.
Change from baseline in both treatment groups of dermatological assessment of the painful area.
Dermatological assessment is measured by Dermatological Assessment Scale (scale range from 0 (without causing irritation) to 7 (important reaction that extends beyond the assessed area).
Time frame: Baseline to 8 weeks.
Grade of compliance/complacency of treatment.
A patient compliance questionnaire (6 questions) will be self-administered to the patient and must be completed during the follow-up visit.
Time frame: Last Follow-Up visit of the study (22nd week).