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: August 25, 2014
Last verified: August 2014

June 30, 2011
August 25, 2014
September 2011
May 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01407471 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Interest of Topical Spironolactone's Administration to Prevent Corticoid-induced Epidermal Atrophy
Interest of Topical Spironolactone's Administration to Prevent Corticoid-induced Epidermal Atrophy

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Cutaneous Atrophy Due to Corticosteroids
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
May 2012
May 2012   (final data collection date for primary outcome measure)

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 ...)
Both
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01407471
P071011
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Société de Dermatologie Française
Principal Investigator: Eve MAUBEC, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
August 2014

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