CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 17 enrolled
Drug / intervention
Imiquimoddrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01935310
NCT01935310N/ACompleted

Clinical and Histological Analysis of Photoaging Treatment With Imiquimod Cream 5%

CES University·interventional·Posted Sep 5, 2013·Updated Sep 5, 2013

In Brief

A clinical study evaluating Imiquimod for Photoaging. Completed, enrolled 17 participants across 1 site.

Detailed Summary

Recently it was demonstrated that imiquimod in addition to exerting a repairing effect in pre malignant and malignant lesions caused by UV radiation it reverses histopathological changes associated with the photoaging skin. This is an experimental exploratory study. It included 17 patients. The patients were diagnosed with photoaging grades III and IV in the scale of Glogau and volunteered to participate in the study. Patients were treated with imiquimod 5% topically, for a time period of 12 weeks. Biopsies were taken from periorbital skin area at baseline and after 4 weeks after completing the treatment. Adverse effects, adherence to therapy and patients' satisfaction were measured. Clinical and histological parameters of photoaging were studied at baseline and after treatment. After completion of treatment with imiquimod, the final clinical evaluation was compared to the initial one.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPhotoaging
CountriesColombia
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 5, 2013
Enrollment StartJul 1, 2010
Primary CompletionNov 1, 2010
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.8 years ago

Interventions

Imiquimoddrug

From the group of subjects who met the inclusion criteria, 22 people were selected randomly (using a random number table) since a 20-25% loss to follow up was calculated and the least amount of patients needed were 17. During the study participants applied imiquimod cream 5% (Virosupril ® laboratories Roemmers) in the periocular area during the night, three times a week, on nonconsecutive days, for 12 weeks (3 months). If patients presented irritative dermatitis a topical 0.05% desonide cream was administered and applied for less of 5 days until symptoms improved.