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Topical Imiquimod in Conjunction With Nd:YAG Laser for Tattoo Removal

This study has been completed.
Sponsor:
Collaborator:
Graceway Pharmaceuticals, LLC
Information provided by (Responsible Party):
Keyvan Nouri, University of Miami
ClinicalTrials.gov Identifier:
NCT00638651
First received: March 12, 2008
Last updated: May 9, 2017
Last verified: May 2017
Results First Received: August 20, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Condition: Healthy
Interventions: Device: 1064 nm Nd:YAG laser
Drug: Imiquimod, 5% cream

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Laser Treatment With Imiquimod Cream or Placebo One participant with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream.

Participant Flow:   Overall Study
    Laser Treatment With Imiquimod Cream or Placebo
STARTED   3 
COMPLETED   3 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Laser Treatment With Imiquimod Cream or Placebo One participant with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream.

Baseline Measures
   Laser Treatment With Imiquimod Cream or Placebo 
Overall Participants Analyzed 
[Units: Participants]
 3 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      3 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1  33.3% 
Male      2  66.7% 


  Outcome Measures

1.  Primary:   Efficacy of Tattoo Removal Using Topical Imiquimod 5% Cream   [ Time Frame: approximately 14 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Keyvan Nouri
Organization: University of Miami
phone: 305-243-3380
e-mail: knouri@med.miami.edu


Publications of Results:

Responsible Party: Keyvan Nouri, University of Miami
ClinicalTrials.gov Identifier: NCT00638651     History of Changes
Other Study ID Numbers: 20071234
Study First Received: March 12, 2008
Results First Received: August 20, 2014
Last Updated: May 9, 2017