A Two-period, Multiple and Single Dose, Randomised, Double-blind, Placebo-controlled, Healthy Volunteer, Phase I Study to Assess Irritation, Sensitization and Adhesion of a Novel Ibuprofen 200 mg TEPI Medicated Plaster
Overview
- Phase
- Phase 1
- Intervention
- Ibuprofen 200 mg TEPI Medicated Plaster
- Conditions
- Healthy
- Sponsor
- Medherant Ltd
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Mean Irritation Score
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This trial will be conducted with the aim to investigate the dermal response (skin irritation, sensitization) and the adhesion of Ibuprofen 200 mg TEPI Medicated Plaster as compared to a Placebo TEPI Plaster in two phases:
Induction Phase: multiple dose application of one active and one placebo plaster on 5 consecutive days in which the plasters remain in place for 23 hours ± 30 min a day and Challenge Phase: single dose application of one active and one placebo plaster which remain in place for 48 hours ± 30 min.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female subject
- •Age between 18 and 65 years
- •Physically and mentally healthy as judged by means of medical and standard laboratory examinations
- •Non-smokers or ex-smokers (stopped at least 6 months ago) with a smoking history of ≤5 pack-year equivalents (1 pack-year equivalent is equal to smoking 1 pack per day for 1 year\*\*\*\*\*) and non-users of other nicotine containing products, confirmed by urine cotinine test
- •Weight ≥ 60 kg and BMI within the range (including the borders) of 18.0 to 30.0 kg/m2
- •Informed consent given in written form.
Exclusion Criteria
- •Participation in another clinical trial at same time or within the preceding 90 days (calculated from the date of the final examination of the previous study)
- •Fertile women without reliable contraception method. List of allowed medically accepted contraceptive methods and the allowed HRT (used at least 4 weeks prior entry visit and not to be changed for the duration of the study):
- •combination of 2 barrier methods: female/male condoms, diaphragms, spermicides
- •intrauterine devices (IUD): inert or copper-releasing or progestinreleasing IUD
- •hormonal methods: combined oestrogen/progestin injectable contraceptives, progestin only injectable contraceptives, Norplant implants, skin patches, NuvaRing®
- •Hormone Replacement Therapy (HRT)
- •voluntary sterilization (female tubal occlusion).
- •Randomisation into the present trial more than once
- •History of drug abuse or use of illegal drugs: use of soft drugs, e.g. marihuana within 6 months of screening or hard drugs, e.g. cocaine, amphetamines, phencyclidine within 1 year of screening
- •Alcohol abuse, i.e. regular use of more than 2 units of alcohol per day or 10 units per week or a history of alcoholism (one unit of alcohol equals 250 ml beer, 125 ml wine or 25 ml spirits) or recovered alcoholics
Arms & Interventions
Test
Ibuprofen 200mg TEPI medicated plaster
Intervention: Ibuprofen 200 mg TEPI Medicated Plaster
Placebo
Placebo TEPI Plaster
Intervention: Placebo TEPI Plaster
Outcomes
Primary Outcomes
Mean Irritation Score
Time Frame: 10 days
Average of Dermal Response Scores Score Definition 0 - No evidence of irritation 1. - Minimal erythema, barely perceptible 2. - Definite erythema, readily visible; minimal oedema or minimal papular response 3. - Erythema and papules 4. - Definite oedema 5. - Erythema, oedema, and papules 6. - Vesicular eruption 7. - Strong reaction spreading beyond test site
Total Cumulative Irritation Score
Time Frame: 10 dyas
Sum of Dermal Response Scores - Score Definition 0 - No evidence of irritation 1. - Minimal erythema, barely perceptible 2. - Definite erythema, readily visible; minimal oedema or minimal papular response 3. - Erythema and papules 4. - Definite oedema 5. - Erythema, oedema, and papules 6. - Vesicular eruption 7. - Strong reaction spreading beyond test site
Secondary Outcomes
- Mean Combined Dermal Response Score(10 days)
- Total Combined Dermal Response Score(10 days)
- Combined Dermal Response Scores(10 days)