Efficacy in Daily Use of a Novel Skin Care Product for the Treatment of Photoaged Skin

May 8, 2017 updated by: Dr Rachel Watson, University of Manchester

Assessment of Efficacy in Daily Use of a Novel Skin Care Product (CG Skin Ltd.) for the Treatment of Photoaged Skin

Photoaged or chronically sun-exposed skin is characterised by a number of clinical features including fine and coarse wrinkles. The pathogenesis of wrinkle formation has yet to be determined fully but recent work suggests that ultraviolet radiation-induced reduction in dermal fibrillin (in the form of fibrillin-rich microfibrils) is important. Using an extended in vivo patch test assay, it has been identified that skin care products - currently marketed by CG Skin Ltd - increase the deposition of these microfibrils in photoaged dermis and hence have the potential to repair photoaged skin. The Investigators now propose to examine the efficacy of the product in randomized, placebo-controlled clinical trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Subjects who satisfy the inclusion/exclusion criteria and who have given their written, witnessed, informed consent will be admitted to the studies. Subjects will be clinically assessed (fine wrinkling, coarse wrinkling, mottled hyperpigmentation, sallowness) and clinical photographs taken prior to instruction on the use of the allocated cream by the study Investigator (product or placebo). Product will be applied daily to the entire face and dorsum of hands, including the wrists and extensor forearm, for six months. Successive follow-up visits (3 visits over a 6-month period) will be made to assess efficacy and safety. Subjects will be randomly allocated to self-treatment with either product or placebo cream using a computer generated code (Research Randomizer; www.randomizer.org).

The primary outcome measure will be treatment efficacy; this will be assessed by the study Investigators as changes in the clinical parameters of photoaging (fine wrinkles, coarse wrinkles, mottled hyperpigmentation, sallowness).

The Investigators will assess two secondary outcome measures: (1) Histological improvement in skin structure. Skin biopsies from the treated extensor forearm will be taken at study initiation and at the end of the six month study period. These biopsies will be evaluated for: (a) epidermal thickness; (b) fibrillin expression and; (c) pro-collagen I expression. (2) Tolerance and irritancy. Tolerance and irritation assessments will be made by recording the occurrence and severity of signs of erythema and scaling. Safety will be evaluated by recording all adverse events experienced by subjects. Any subject exhibiting adverse events of sufficient severity will be withdrawn from the trial. Completion or withdrawal of subjects from the trial will be noted on the end of study form. All subjects will be monitored for the occurrence of serious adverse events up to, and including, 28 days after their involvement with this study.

The trial will be conducted according to the recommendations of ICH GCP and those of the Declaration of Helsinki, only after approval of the study has been obtained from the relevant Research Ethics Committee.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • Salford, United Kingdom, M6 8HD
        • Dermatopharmacology Unit, Salford Royal NHS Foundation Trust

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have moderate to severe photoaging of facial skin (grade 6 or above on the Griffiths scale);
  • Willing to submit to examination of facial skin, hands and forearms;
  • Willing to submit to self-treatment with product or placebo cream on face, hands and forearms, including wrists and extensor forearms, for 6 months;
  • Willing to submit to clinical photography;
  • Willing to submit to 3 mm punch biopsies from the wrist at beginning and end of trial;
  • Signed informed consent.

Exclusion Criteria:

  • Skin disease that would impair evaluation of the test sites;
  • Topical or systemic retinoid within the past 6 months and 12 months respectively prior to entry to the study;
  • Topical steroid or other topical drugs at treatment sites for at least two weeks prior to study entry;
  • History of use of experimental drug or experimental device in the 30 days prior to entry into the study;
  • Any significant cosmetic treatment for skin rejuvenation i.e. dermabrasion, chemical peels, face-lifts;
  • Known allergy to any of the product or placebo ingredients;
  • History of keloid scars.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
Topical anti-aging cosmetic cream (active)
Other: Topical anti-aging cosmetic cream
Topical anti-aging cosmetic cream
Placebo Comparator: Placebo
Basic formulation without active ingredients (vehicle)
Other: Topical anti-aging cosmetic cream
Topical anti-aging cosmetic cream

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in clinical appearance using a validated photonumeric wrinkle scale
Time Frame: Six (6) months
Change in grade of facial wrinkles as assessed by a clinically competent researcher, using a validated photonumeric wrinkle scale (Griffiths et al., Arch Dermatol., 1992). Assessment of wrinkle grade will be made at baseline and at each follow-up appointment; clinical photography will be performed at each visit for subsequent quantitative image analysis of wrinkle effacement.
Six (6) months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Histological improvement in skin structure
Time Frame: Six (6) months
Histology to assess dermal elastic fibres and the collagenous extracellular matrix
Six (6) months
Tolerance and irritancy
Time Frame: Up to seven (7) months
Assessments will be made by recording the occurrence and severity of signs of erythema and scaling
Up to seven (7) months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manchester

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rachel E Watson, PhD, University of Manchester

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CGC03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Source data will be shared with the study funder (CG Skin Ltd) on completion of the study and will collaborators at the University's Biostatistics Collaboration Unit.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Photoaging

Clinical Trials on Topical anti-aging cosmetic cream

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings