NCT02355639

Brief Summary

The purpose of this study is to assess steroid induced skin atrophy by sonography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 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

January 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

February 24, 2025

Status Verified

May 1, 2017

Enrollment Period

3 months

First QC Date

January 27, 2015

Last Update Submit

February 21, 2025

Conditions

Skin and Connective Tissue Diseases

Outcome Measures

Primary Outcomes (1)

  • Change in skin thickness from baseline to end of treatment

    4 weeks

Secondary Outcomes (1)

  • Relation of clinical features (skin transparency and telangiectasia) to the steroid induced skin atrophy after end of treatment

    4 weeks

Study Arms (3)

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

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

Eligibility Criteria

Age25 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers, 25 to 40 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)

Charité - Universitaetsmedizin Berlin, Department of Dermatology and Allergy

Berlin, 10117, Germany

Location

Related Links

MeSH Terms

Conditions

Skin and Connective Tissue Diseases

Interventions

ClobetasolOintmentsbetamethasone-17,21-dipropionate

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

January 27, 2015

First Posted

February 4, 2015

Study Start

January 1, 2015

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

February 24, 2025

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)