Earliest Stage Treatment of Aktinic Keratosis With Imiquimod 3.75% Cream

• Sponsor: Medical University of Graz (Other)
• Overall Status: Completed
• CT.gov ID: NCT04842422
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arm: 1
• Actual Duration (Months): 4.2
• Patients Per Site Per Month: 11.3

Study Details

Study Description

Brief Summary

Earliest Stage Treatment of Actinic Keratosis with Imiquimod 3.75% Cream:

The study is to demonstrate that Aktinic Keratosis are present before they are clinically visible, i.e. in a subclinical stage. Since on the basis of the research situation, also subclinical AK can proliferate into the dermis, it is possible that with the application of Imiquimod on chronically light-exposed skin, undetected squamous cell carcinoma can be recognized and treated at the same time.

Condition or Disease	Intervention/Treatment	Phase
Actinic Keratoses	Drug: Imiquimod 3.75% Cream	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Earliest Stage Treatment of Aktinic Keratosis With Imiquimod 3.75% Cream
• Actual Study Start Date: Apr 16, 2021
• Actual Primary Completion Date: Aug 23, 2021
• Actual Study Completion Date: Aug 23, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Earliest Stage Treatment of Aktinic Keratosis	Drug: Imiquimod 3.75% Cream; Imiquimod 3.75% Cream

Outcome Measures

Primary Outcome Measures

1. immunomodulatory-induced inflammatory reaction [two weeks]

   Percentage of subjects in whom an immunomodulatory-induced inflammatory reaction occurs on chronically light-exposed uv-damaged facial skin after two weeks.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion

• Male and female supposed-healthy volunteer outpatients, age: > 50 years.

• Diagnosis: patients with chronically UV-exposed photodamaged facial skin.

• Consent by signing the ICF (Informed Consent Form)

Exclusion

• Current participation in another clinical trial

• Patients who are using topical glucocorticoids on the face.

• Known intolerance/hypersensitivity to imiquimod

• Pregnant/breastfeeding women

• Systemic disease, immunodeficiency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinik für Dermatologie und Venerologie	Graz		Austria	8010

Sponsors and Collaborators

• Medical University of Graz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of Graz
• ClinicalTrials.gov Identifier: NCT04842422
• Other Study ID Numbers: 12020
• First Posted: Apr 13, 2021
• Last Update Posted: Jan 11, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Keratosis, Actinic; Keratosis; Imiquimod

Study Results

No Results Posted as of Jan 11, 2022