Phase I Study to Assess Irritation, Sensitization and Adhesion of a Novel Ibuprofen 200 mg TEPI Medicated Plaster

NCT03639571 | Completed Phase 1

• 1 other identifier: MED-IBU-102
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Mean Irritation Score

  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

  10 days

• Total Cumulative Irritation Score

  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

  10 dyas

Secondary Outcomes (3)

• Mean Combined Dermal Response Score

  10 days

• Total Combined Dermal Response Score

  10 days

• Combined Dermal Response Scores

  10 days

Study Arms (2)

Test

EXPERIMENTAL

Ibuprofen 200mg TEPI medicated plaster

Drug: Ibuprofen 200 mg TEPI Medicated Plaster

Placebo

PLACEBO COMPARATOR

Placebo TEPI Plaster

Other: Placebo TEPI Plaster

Interventions

Ibuprofen 200 mg TEPI Medicated Plaster DRUG

Ibuprofen 200 mg TEPI Medicated Plaster, manufactured by AdhexPharma, France on behalf of Medherant Ltd., UK

Test

Placebo TEPI Plaster OTHER

Placebo TEPI Plaster, manufactured by AdhexPharma, France on behalf of Medherant Ltd., UK

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Positive drug screening and/or positive alcohol test at entry (screening) visit, or on Day -1, or on Day 19
• Pregnant and/or nursing women. Positive pregnancy test at entry (screening) visit, or on Day -1, or on Day 19
• Allergic diathesis or any clinically significant allergic disease (i.e. asthma or bronchial hyper-reactivity, contact dermatitis)
• Known allergy to sticking plaster or to the ingredients of the products
• Dermatologic disease that might interfere with the evaluation of test site reaction

Sponsors & Collaborators

• Medherant Ltd: lead
• Cooperative Clinical Drug Research and Development AG (CCDRD AG): collaborator

Study Sites (1)

MHAT

Sofia, Bulgaria

Location

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 21, 2018
• Study Start: August 9, 2018
• Primary Completion: October 25, 2018
• Study Completion: October 25, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)