NCT02392130

Brief Summary

The purpose of this study is to assess the effect of LEO 130852A gel 1% in maintaining skin thickness in healthy skin treated with steroid.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 24, 2025

Status Verified

May 1, 2017

Enrollment Period

3 months

First QC Date

March 6, 2015

Last Update Submit

February 21, 2025

Conditions

Skin Tissue DiseasesConnective Tissue Diseases

Outcome Measures

Primary Outcomes (1)

  • Skin thickness measured by sonography and histology

    4 weeks

Secondary Outcomes (2)

  • Clinical assessments measured by atrophy score

    4 weeks

  • Clinical assessments measured by telangiectasia score

    4 weeks

Study Arms (3)

Active Drug

ACTIVE COMPARATOR

Clobetasol propionate 0.05% ointment

Drug: Clobetasol propionate 0.05% ointment

Experimental Drug

EXPERIMENTAL

LEO 130852A gel 1%

Drug: LEO 130852A gel 1%

Placebo Drug

PLACEBO COMPARATOR

LEO 130852A placebo gel

Drug: LEO 130852A placebo gel

Interventions

Clobetasol propionate 0.05% ointmentDRUG
Active Drug
LEO 130852A gel 1%DRUG
Experimental Drug
LEO 130852A placebo gelDRUG
Placebo Drug

Eligibility Criteria

Age25 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers, 25 to 50 years old inclusive
  • Healthy skin on volar arms with a hairless area sufficient for measurements

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

bioskin GmbH

Hamburg, 20095, Germany

Location

Related Links

MeSH Terms

Conditions

Connective Tissue Diseases

Interventions

ClobetasolOintments

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BetamethasoneSteroids, FluorinatedSteroidsFused-Ring CompoundsPolycyclic CompoundsDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2015

First Posted

March 18, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

February 24, 2025

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)