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

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ClinicalTrials.gov Identifier: NCT00638651
Recruitment Status : Completed
First Posted : March 19, 2008
Results First Posted : September 1, 2014
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
Graceway Pharmaceuticals, LLC
Information provided by (Responsible Party):
Keyvan Nouri, University of Miami

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Healthy
Interventions Device: 1064 nm Nd:YAG laser
Drug: Imiquimod, 5% cream
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Laser Treatment With Imiquimod Cream or Placebo
Hide Arm/Group Description Participants with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream.
Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title Laser Treatment With Imiquimod Cream or Placebo
Hide Arm/Group Description One participant with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream.
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
1.Primary Outcome
Title Efficacy of Tattoo Removal Using Topical Imiquimod 5% Cream
Hide Description To evaluate the efficacy of tattoo removal using topical imiquimod, 5% cream (Aldara™, 3M/Graceway Pharmaceuticals, an immune response modifier) in conjunction with the 1064 nm Nd:YAG laser. This procedure for tattoo removal will be compared to laser removal alone.
Time Frame approximately 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Laser Treatment With Imiquimod (Group 1) Laser Treatment With Placebo Cream (Group 2)
Hide Arm/Group Description:

The tattoo will be treated with laser and imiquimod 5% cream

1064 nm Nd:YAG laser: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy

Imiquimod, 5% cream: 2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month

The tattoo will be treated with laser and placebo topical cream

1064 nm Nd:YAG laser: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy

Overall Number of Participants Analyzed 3 3
Overall Number of Units Analyzed
Type of Units Analyzed: Tattoo
3 3
Mean (Full Range)
Unit of Measure: percentage of tattoo pigment removed
4.3
(0 to 5)
2.7
(0 to 5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Laser Treatment With Imiquimod Cream or Placebo
Hide Arm/Group Description One participant with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream.
All-Cause Mortality
Laser Treatment With Imiquimod Cream or Placebo
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Laser Treatment With Imiquimod Cream or Placebo
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Laser Treatment With Imiquimod Cream or Placebo
Affected / at Risk (%)
Total   0/3 (0.00%) 
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
Responsible Party: Keyvan Nouri, University of Miami
ClinicalTrials.gov Identifier: NCT00638651     History of Changes
Other Study ID Numbers: 20071234
First Submitted: March 12, 2008
First Posted: March 19, 2008
Results First Submitted: August 20, 2014
Results First Posted: September 1, 2014
Last Update Posted: March 22, 2018