Status:

COMPLETED

Melanil in the Treatment of Melasma

Lead Sponsor:

Catalysis SL

Conditions:

Melasma

Eligibility:

All Genders

18-75 years

Phase:

PHASE3

Brief Summary

The purpose of the study is to assess the efficacy of Melanil facial cream in the treatment of melasma. The duration of this double-blind phase 3 clinical trial will be 54 weeks. The control group wil...

Eligibility Criteria

Inclusion

  • Clinical diagnosis of Melasma
  • Fitzpatrick's skin types I to IV
  • Signed informed consent
  • Given verbal agreement on protection from UV light during treatment by the usage of physical barriers (umbrellas, caps, hats, etc).

Exclusion

  • Fitzpatrick's skin types V and VI
  • Treatment with steroids within the duration of the clinical trial.
  • Oral contraception within the duration of the clinical trial
  • Usage of other cosmetics within the duration of the clinical trial
  • Treatment with Clofazimine within the duration of the clinical trial

Key Trial Info

Start Date :

October 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2010

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT01001624

Start Date

October 1 2009

End Date

November 1 2010

Last Update

May 4 2012

Active Locations (1)

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1

"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital

Havana, La Habana, Cuba, 10400