Photoaging Treatment With Imiquimod

August 30, 2013 updated by: Sol Beatriz Jiménez, CES University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An experimental study was conducted between July and November 2010 in order to evaluate the efficacy and safety of imiquimod as a treatment option for photoaging.

The sample population was made up of individuals from both genders, older than 40 years, who worked at a flower growing farm located in a rural area of Rionegro (Antioquia) with an altitude of 2,125 meters above sea level; approximately composed of 80 people.

The sample size was calculated considering improvements in 50% or more of patients had to be detected, with a confidence interval of 95%, a power of 80%, a sampling error of 5%.

There were five visits: one at baseline and at months 1, 2, 3 and 4. In each visit patients were assesed clinically, a photograph was taken and adherence and side effects were investigated. Treatment was given during the first 3 months. A biopsy was taken at baseline and during the 4th month assessment. The last visit for clinical monitoring, photographic follow up and skin biopsy was at 16 weeks (4 weeks after discontinuation of the medication). In this last visit patient's satisfaction was evaluated through a survey.

The clinical assessment of photodamage performed by two dermatologists independently included: Changes in texture: dryness/roughness; changes in color: mottled hyperpigmentation, lentigines, yellowing; wrinkles: fine, deep wrinkles and laxity; telangiectasias.

Clinical signs like dryness, burning, erythema, itching, fissures and scabs were used to measure skin irritation.

Severity for the parameters measured in the clinical assessment of photoaging and the assessment of skin irritation was graded on a point scale of 0-3 where 0 was absence, one was mild, 2 moderate and 3 severe.

Biopsies were taken from sites adjacent to the temporal facial area. Aseptic iodine solution was used on the selected area, then the biopsy site was infiltrated with lidocaine 2% (about 0.5 cc) with a short 30-gauge needle and once analgesia was obtained a punch biopsy number 4 mm was taken. The skin biopsy was kept in a jar with formalin properly labeled and sent for histopathology. Then the biopsy site was sutured with 5-0 prolene. The biopsies were sent to the pathology department of the CES University for hematoxylin-eosin staining and they were blind - read by two dermatopathologists who evaluated the following parameters: epidermal changes: epidermal thickness, thickness of the granular layer, melanin content, atypia of melanocytes and keratinocytes, dermal-epidermal junction: pigment incontinence; dermis: inflammation, solar elastosis, fibrosis in the papillary dermis and telangiectasia.

Adherence was measured by asking patients in each one of the visits and it was considered excellent when the drug was applied 3 times per week, regular if the patient missed 2-3 applications between visits and poor if he/she missed more than 5 applications.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050021
        • Centro de servicios CES Sabaneta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with Fitzpatrick's skin types I to IV, with a photoaging equal to or greater than 3 on the Glogau measuring scale, who had not used systemic retinoids for over four weeks during six months prior to baseline,
  • Patients nor had they undergone chemical peels or used exfoliants or applied botulinum toxin or any other abrasive substance on the face six months prior baseline
  • patients that had not used topical retinoids or steroids two months prior to baseline
  • patients that had not undergone facial rejuvenation surgery 12 months prior to treatment.

Exclusion Criteria:

  • pregnant or nursing women
  • patients currently being treated with phototherapy
  • patients currently being treated with photochemotherapy or whom were scheduled to start
  • patients with suspected skin cancer assessed by clinical examination
  • patients with dermatological conditions with changes in the texture or color of the skin
  • Patients with inflammatory dermatoses, immunological, infectious, or neoplastic skin diseases located in the periocular area since it could interfere with the clinical assessment of photoaging.
  • Patients that at the time of inclusion expressed treatment refusal, disinterest or inability to comply with the protocol as well as those with skin types V and VI were not included.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: imiquimod use in photoaging
Evaluate the efficacy and safety of imiquimod as a treatment option for photoaging photoaging equal to or greater than 3.
Drug: Imiquimod

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.

Other Names:
  • Virosupril®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of clinical response by percentage of improvement
Time Frame: 8 weeks

To determine the degree of patient improvement percentages were set according to the values obtained in the first and last measurement as follows:

For ordinal clinical variables that had 4 categories the following percentages were established: Slight 1-point improvement (1-32%), moderate 2-point improvement (33-66%), good 3-point improvement (> 66%), same or worse, one or more points of deterioration (<= 0%).

For ordinal histological variables that were 4 categories the calculated improvement percentages were equal to the ones just described and for those with 5 variables, the established percentages were as follows: Slight 1-point improvement (1-25%), moderate 2-point improvement (26-50%), good 3-point improvement (51-75%), excellent 4-point improvement (> 75%), one or more points of deterioration (<= 0%).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CES University

Investigators

  • Study Director: Sol Beatriz Jiménez, MD, CES University
  • Principal Investigator: Lucía Salinas, MD, CES University
  • Principal Investigator: Ana Cristina Ruíz, MD, CES University
  • Principal Investigator: Natalia De la Calle, MD, CES University
  • Principal Investigator: María Alejandra Zuluaga, MD, CES University
  • Principal Investigator: Rubén Darío Manrique, PhC, CES University
  • Principal Investigator: Bibiana Castro, MSc, CES University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

August 14, 2013

First Submitted That Met QC Criteria

August 30, 2013

First Posted (Estimate)

September 5, 2013

Study Record Updates

Last Update Posted (Estimate)

September 5, 2013

Last Update Submitted That Met QC Criteria

August 30, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMQ003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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