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

• Sponsor: University of Miami (Other)
• Overall Status: Completed
• CT.gov ID: NCT00638651
• Collaborator: Graceway Pharmaceuticals, LLC (Industry)
• Enrollment: 3
• Location: 1
• Arms: 2
• Duration (Months): 78
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of tattoo removal using topical imiquimod, 5% cream in conjunction with the 1064nm Nd:YAG laser. This procedure for tattoo removal will be compared to a laser removal alone.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: 1064 nm Nd:YAG laser; Drug: Imiquimod, 5% cream	Phase 1

Detailed Description

Inclusion criteria includes: patients of both genders with Fitzpatrick skin types I-IV who are 18-65 years of age and who has 2 tattoos from 2 to 10 cm in diameter, of similar age which contains black and/or blue ink in areas that can be covered. Exclusion criteria includes: tattoos in chronically sun exposed areas, larger than 25 cm2,pregnancy,breast feeding state, immunosuppressed patients, history of autoimmune or connective tissue disorders, hypersensitivity to imiquimod, active sunburn, current tan, use of coumadin, aspirin , vitamin E or non-steroidal anti-inflammatory agents for the past 10 days.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Topical Imiquimod in Conjunction With Nd:YAG Laser for Tattoo Removal
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 The tattoo will be treated with laser and imiquimod 5% cream	Device: 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; Drug: Imiquimod, 5% cream; 2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month; Other Names: Aldara
Placebo Comparator: 2 The tattoo will be treated with laser and placebo topical cream	Device: 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

Outcome Measures

Primary Outcome Measures

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

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 2 tattoos no larger than 25cm2, professionally made, with approximately the same age, containing blue/black ink.

Exclusion Criteria:

• Hypersensitivity to imiquimod

• Current sun tan

• Use of vitamin E, non-steroid anti-inflammatory drugs, coumadin or aspirin for the past 10 days

• Amateur tattoos

• Pregnancy

• Breast-feeding status

• Immunosuppression

• Auto-immune diseases.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mohs, Dermatologic and Laser Surgery	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami
• Graceway Pharmaceuticals, LLC

Investigators

• Principal Investigator: Keyvan Nouri, MD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Principal investigator biography

Publications

None provided.

• Responsible Party: Keyvan Nouri, MD, University of Miami
• ClinicalTrials.gov Identifier: NCT00638651
• Other Study ID Numbers: 20071234
• First Posted: Mar 19, 2008
• Last Update Posted: Mar 22, 2018
• Last Verified: Feb 1, 2018

• Keywords provided by Keyvan Nouri, MD, University of Miami: Tattoos; Black/blue tattoos
• Additional relevant MeSH terms: Imiquimod

Study Results

Participant Flow

Arm/Group Title	Laser Treatment With Imiquimod Cream or Placebo
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

Baseline Characteristics

Arm/Group Title	Laser Treatment With Imiquimod Cream or Placebo
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 Participants	3
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	3 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	1 33.3%
Male	2 66.7%

Outcome Measures

1. Primary Outcome

Title	Efficacy of Tattoo Removal Using Topical Imiquimod 5% Cream
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Laser Treatment With Imiquimod (Group 1)	Laser Treatment With Placebo Cream (Group 2)
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
Measure Participants	3	3
Measure Tattoo	3	3
Mean (Full Range) [percentage of tattoo pigment removed]	4.3	2.7

Adverse Events

Arm/Group Title	Laser Treatment With Imiquimod Cream or Placebo
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Laser Treatment With Imiquimod Cream or Placebo
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Other (Not Including Serious) Adverse Events
	Laser Treatment With Imiquimod Cream or Placebo
	Affected / at Risk (%)	# Events
Total	0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.