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

This study has been completed.

Sponsor:

Collaborator:

Société de Dermatologie Française

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT01407471

First received: June 30, 2011

Last updated: May 14, 2012

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 30, 2011

Last Updated Date

May 14, 2012

Start Date ^ICMJE

September 2011

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

histological measure of epidermal thickness [ Time Frame: day 29 ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01407471 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

delay of healing after skin biopsies performed on day 29 [ Time Frame: days 32, 36, 39, 43, 46, 50 ] [ Designated as safety issue: No ]
Dermis thickness evaluated by ultrasound [ Time Frame: days 1, 15, 29 ] [ Designated as safety issue: No ]
Mineral receptors and glucoreceptors expression ratio performed by immunohistochemistry [ Time Frame: day 29 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

The purpose of this study is to determine whether spironolactone could significantly reduce cutaneous atrophy due to corticosteroids.

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Cutaneous Atrophy Due to Corticosteroids

Intervention ^ICMJE

Drug: Clobetasol + Spironolactone
One application 6 days a week during 4 weeks

Other Name: Clobetasol + Spironolactone
Drug: Clobetasol + Placebo
One application 6 days a week during 4 weeks

Other Name: Clobetasol + Placebo
Drug: Placebo + Spironolactone
One application 6 days a week during 7 weeks

Other Name: Placebo + Spironolactone
Drug: Placebo + Placebo
One application 6 days a week during 7 weeks

Other Name: Placebo + Placebo

Study Arm (s)

Experimental: Clobetasol + Spironolactone
0.05% clobetasol and 5% spironolactone

Intervention: Drug: Clobetasol + Spironolactone
Active Comparator: Clobetasol + Placebo
0.05% clobetasol + inert excipient

Intervention: Drug: Clobetasol + Placebo
Active Comparator: Placebo + Spironolactone
Inert excipient + 5% spironolactone

Intervention: Drug: Placebo + Spironolactone
Placebo Comparator: Placebo + placebo
Inert excipient

Intervention: Drug: Placebo + Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2012

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ...)

Gender

Both

Ages

20 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01407471

Other Study ID Numbers ^ICMJE

P071011

Has Data Monitoring Committee

Responsible Party

Assistance Publique - Hôpitaux de Paris

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Société de Dermatologie Française

Investigators ^ICMJE

Principal Investigator:

Eve MAUBEC, MD

Assistance Publique - Hôpitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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