Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Arms and Hands

Vehicle-Controlled, Double-Blind Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Upper Extremities

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00115154

Enrollment

270

Registered

2005-06-22

Start date

2005-05-31

Completion date

2006-09-30

Last updated

2007-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratosis

Keywords

Actinic Keratosis, AK, 3M Pharmaceuticals, Aldara, Imiquimod, Actinic Keratosis (AK)

Brief summary

The purpose of this study is to evaluate the safety and efficacy of imiquimod 5% cream compared to vehicle cream in the treatment of Actinic Keratosis (AK) on the arm and/or hand when the cream is applied once daily 2 days per week for 16 weeks.

Interventions

DRUGAldara (imiquimod) cream, 5%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 18 years of age * Have AK on arm or hand * Discontinuation of sun tanning and the use of tanning beds * Discontinuation of the use of moisturizers, body oils, over-the-counter retinol products and products containing alpha or beta hydroxy acid in the treatment and surrounding area * Withholding of the use of sunscreen in the treatment area for 24 hours prior to all study visits and for 8 hours before applying study cream * Postponement of the treatment of non-study AK lesions anywhere on the arm being treated until study participation is complete

Exclusion criteria

* Subjects must not have any evidence of systemic cancer or immunosuppression or other unstable health conditions * Participation in another clinical study * Have previously received treatment with imiquimod within the treatment area * Have squamous cell carcinoma (SCC), basal cell carcinoma (BCC), or other malignancy in the treatment or surrounding area that requires treatment

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is to evaluate the efficacy of imiquimod 5% cream compared to vehicle cream in the treatment of AK on the upper extremities when the cream is applied once daily 2 days per week for 16 weeks.	—

Secondary

Measure	Time frame
The secondary objective is to evaluate the safety of treatment with imiquimod 5% cream in subjects with AK lesions on the upper extremities.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026