Comparative Safety Study of New Sinecort Formulation Versus Positive Control

NCT00885937 | Completed Phase 1

• 3 other identifiers: 139412008-008138-36Sinecort
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The study is focused to prove a favorable safety profile of the new formulation.

Conditions

Healthy

Keywords

Dexpanthenol; Safety,; New formulation; Topical administration

Outcome Measures

Primary Outcomes (1)

• Irritation rate

  After 21 applications

Secondary Outcomes (1)

• Irritation potential

  After 21 applications

Study Arms (3)

Arm 1

EXPERIMENTAL

Drug: Dexpanthenol (Sinecort, BAY81-2996)

Arm 2

ACTIVE COMPARATOR

Drug: Positive control, Na-laurylsulfat-solution

Arm 3

PLACEBO COMPARATOR

Device: Untreated skin under application chamber

Interventions

Dexpanthenol (Sinecort, BAY81-2996) DRUG

1 squeeze of Sinecort cream sufficient to cover the area of the application chamber, (=50 mikro liter)

Arm 1

Positive control, Na-laurylsulfat-solution DRUG

50 mikro liter of 0.5 % Sodium-laurylsulfate-solution

Arm 2

Untreated skin under application chamber DEVICE

Application of treatment chamber as in arm 1 and arm 2 on untreated skin

Arm 3

Eligibility Criteria

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

You may qualify if:

• Age of at least 18 years
• Skin type I, II, or III according to Fitzpatrick
• Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception.

You may not qualify if:

• Clinical history suggestive of intolerance, allergies or idiosyncrasies to one of the products or the ingredients of the products including the patch.
• Known skin allergies.
• Dermatologic diseases that might interfere with the evaluation of test site reaction.
• Other(s), considered as important by the investigator (e.g. multiple birth marks in the test area, important hair growth in the test area, pigmented or extremely suntanned skin impairing visual assessment, tattoos in the test area.
• Topical use of any cosmetic preparation on the test areas within 5 days prior to Day 1 (Start of Treatment) or during the trial
• Within 3 weeks prior to Day 1 and during the entire trial. Any systemic or topical medication likely to interfere with the trial purposes: e.g. immune-modulating therapy (e.g. corticosteroids, cytotoxics or immunosuppressants) and any dermatological medication (drug or medical device.
• Within 1 week prior to Day 1 and during the entire trial any medication with common effects on the perfusion of skin vessels (e.g. vasodilators or vasoconstrictors, ß-receptor blocking drugs, antihistamines) should not be used.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Münster, North Rhine-Westphalia, 48155, Germany

Location

MeSH Terms

Interventions

dexpanthenol

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2009
• First Posted: April 22, 2009
• Study Start: April 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 23, 2014

Record last verified: 2014-06

Locations

DE (1)