Trial Outcomes & Findings for Topical Imiquimod in Conjunction With Nd:YAG Laser for Tattoo Removal (NCT NCT00638651)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

3 participants

Primary outcome timeframe

approximately 14 weeks

Results posted on

2018-03-22

Participant Flow

Participant milestones

Participant milestones
Measure	Laser Treatment With Imiquimod Cream or Placebo Participants with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laser Treatment With Imiquimod Cream or Placebo n=3 Participants One participant with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream.
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=39 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants
Sex: Female, Male Female	1 Participants n=39 Participants
Sex: Female, Male Male	2 Participants n=39 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Laser Treatment With Imiquimod (Group 1) n=3 Tattoo 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	Laser Treatment With Placebo Cream (Group 2) n=3 Tattoo 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
Efficacy of Tattoo Removal Using Topical Imiquimod 5% Cream	4.3 percentage of tattoo pigment removed Interval 0.0 to 5.0	2.7 percentage of tattoo pigment removed Interval 0.0 to 5.0

Adverse Events

Laser Treatment With Imiquimod Cream or Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Keyvan Nouri

University of Miami

Phone: 305-243-3380

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place