A Single-Centre Clinical Trial to Assess Steroid Induced... | NCT02355639

Studies
A Single-Centre Clinical Trial to Assess Steroid Induced Skin Atrophy on Healthy Skin

NCT02355639

Sponsor

LEO Pharma

Status

Completed

Last Update Posted

Feb 24, 2025Actual

Enrollment

16Actual

Phase

Phase 1

Conditions

Skin and Connective Tissue Diseases

Interventions

Clobetasol propionate 0.05 % ointment
Betamethasone dipropionate 0.064 % ointment
Petrolatum ointment

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Jan 27, 2015

First Submission Date that Met QC Criteria

Jan 30, 2015

First Posted Date

Feb 4, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2025

Last Update Posted Date

Feb 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Clobetasol propionate 0.05 % ointment	Experimental	Active drug	Drug: Clobetasol propionate 0.05 % ointment
Betamethasone dipropionate 0.064 % ointment	Experimental	Active drug	Drug: Betamethasone dipropionate 0.064 % ointment
Petrolatum ointment	Placebo Comparator	Placebo drug	Drug: Petrolatum ointment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clobetasol propionate 0.05 % ointment	Drug		Clobetasol propionate 0.05 % ointment
Betamethasone dipropionate 0.064 % ointment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in skin thickness from baseline to end of treatment		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Relation of clinical features (skin transparency and telangiectasia) to the steroid induced skin atrophy after end of treatment		4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male volunteers, 25 to 40 years old inclusive.
Healthy skin on volar arms with a hairless area sufficient for measurements

Exclusion Criteria:

Clinical skin atrophy, telangiectasia or striae on volar arms.
Presence of any skin condition or colouration that would interfere with test sites or the response or assessment.
Fitzpatrick skin type IV - VI.
History or current evidence of infection, eczema or other relevant skin disease.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité - Universitaetsmedizin Berlin, Department of Dermatology and Allergy		Berlin		10117	Germany

Label	URL
Clinical Trials at LEO Pharma	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017437	Skin and Connective Tissue Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002990	Clobetasol
D009824	Ointments
C011175	betamethasone-17,21-dipropionate

Ancestor Terms

ID	Term
D001623	Betamethasone
D013259	Steroids, Fluorinated
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided