Interest of Topical Spironolactone's Administration to Prevent Corticoid-induced Epidermal Atrophy (SPIREPI)

July 2, 2015 updated by: Assistance Publique - Hôpitaux de Paris
The purpose of this study is to determine whether spironolactone could significantly reduce cutaneous atrophy due to corticosteroids.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

skin cutaneous atrophy due to corticosteroids limits the long-term use of highly potent topical glucocorticoids which are the treatment of choice for many inflammatory skin diseases. This atrophy results in fragile skin, delay of healing, purpura, irreversible striae, telangiectasia and secondary infections. Up to now, no treatments can prevent efficiently skin atrophy.

The mineralocorticoid receptor, belonging to the superfamily of nuclear receptors, is expressed in human epidermis but its actual function is unknown. Experimental results in animals obtained in INSERM unit U772 by Dr N FARMAN suggest that spironolactone which is a mineralocorticoid receptor antagonist 1- might limit epidermal atrophy and 2- might promote healing.

Study description We propose to test clinically these hypotheses for the first time on humans, at the CIC in BICHAT's hospital on healthy volunteers: 1- by applying on the skin a highly potent cutaneous corticosteroids in association or not with spironolactone, 2- by applying or not spironolactone on wounds after 3-mm punch biopsies.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75877
        • Bichat hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers of both sex, aged between 20 and 50 years
  • Woman with effective contraception and pregnancy test negative before inclusion.
  • Subject considered healthy after a detailed review (interview, clinical examination)
  • Subject belonging to a social security scheme (beneficiary or have the right)
  • Subject having signed a free and informed consent
  • Integrity of the skin at forearms
  • Subject available the next 7 weeks and able to go to CIC once a day from Monday to Friday
  • Subject accepting four skin biopsies at D29
  • no washing forearms during 2 hours after applications

Exclusion Criteria:

  • Chronic Alcoholism
  • Drug-addiction (comprehensive interview with a sampling in case of doubt)
  • Woman pregnant or breast-feeding
  • Subject involved in another trial or in exclusion period of another protocol
  • Subject has already received more than 3700 Euros in compensation for damages suffered constraints in the past 12 months for his involvement in biomedical researches
  • Subject has already participated in this protocol
  • Phototypes 5 and 6
  • Clinical skin atrophy
  • History of severe chronic skin disease
  • Problems of healing
  • Treatment with oral corticosteroids, mineralocorticoids or spironolactone (Aldactone, Flumach, Practon, Spiroctan, Spironone, Aldactazine, ALDALIX, Practazin, Spiroctazine ...)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clobetasol + Spironolactone
0.05% clobetasol and 5% spironolactone
Drug: Clobetasol + Spironolactone
One application 6 days a week during 4 weeks
Active Comparator: Clobetasol + Placebo
0.05% clobetasol + inert excipient
Drug: Clobetasol + Placebo
One application 6 days a week during 4 weeks
Active Comparator: Placebo + Spironolactone
Inert excipient + 5% spironolactone
Drug: Placebo + Spironolactone
One application 6 days a week during 7 weeks
Placebo Comparator: Placebo + placebo
Inert excipient
Drug: Placebo + Placebo
One application 6 days a week during 7 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
histological measure of epidermal thickness
Time Frame: day 29
biopsies will be performed in the center of the treated sites. Epidermal thickness will be measured from the basal lamina to the lower border of the stratum corneum. This will be determined by image analysis from the average of fields per skin section.
day 29

Secondary Outcome Measures

Outcome Measure
Time Frame
delay of healing after skin biopsies performed on day 29
Time Frame: days 32, 36, 39, 43, 46, 50
days 32, 36, 39, 43, 46, 50
Dermis thickness evaluated by ultrasound
Time Frame: days 1, 15, 29
days 1, 15, 29
Mineral receptors and glucoreceptors expression ratio performed by immunohistochemistry
Time Frame: day 29
day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Société de Dermatologie Française

Investigators

  • Principal Investigator: Eve MAUBEC, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

June 30, 2011

First Submitted That Met QC Criteria

August 1, 2011

First Posted (Estimate)

August 2, 2011

Study Record Updates

Last Update Posted (Estimate)

July 3, 2015

Last Update Submitted That Met QC Criteria

July 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P071011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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