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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03144193
Recruitment Status : Unknown
Verified May 2017 by Dr Rachel Watson, University of Manchester.
Recruitment status was:  Not yet recruiting
First Posted : May 8, 2017
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Rachel Watson, University of Manchester

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Photoaging Other: Topical anti-aging cosmetic cream Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Assessment of efficacy of a novel anti-aging topical treatment compared to a placebo control
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: Assessment of Efficacy in Daily Use of a Novel Skin Care Product (CG Skin Ltd.) for the Treatment of Photoaged Skin
Estimated Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Histological improvement in skin structure [ Time Frame: Six (6) months ]
    Histology to assess dermal elastic fibres and the collagenous extracellular matrix

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144193


Contacts
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Contact: Rachel E Watson, PhD +441612755505 rachel.watson@manchester.ac.uk
Contact: Jean Y Bastrilles, RCN +442064282 jean.bastrilles@manchester.ac.uk

Locations
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United Kingdom
Dermatopharmacology Unit, Salford Royal NHS Foundation Trust
Salford, United Kingdom, M6 8HD
Contact: Jean Y Bastrilles, RCN    +441612064282    jean.bastrilles@manchester.ac.uk   
Principal Investigator: Rachel E Watson, PhD         
Sponsors and Collaborators
University of Manchester
Investigators
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Principal Investigator: Rachel E Watson, PhD University of Manchester
Publications:
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Responsible Party: Dr Rachel Watson, Reader in Dermatology, University of Manchester
ClinicalTrials.gov Identifier: NCT03144193    
Other Study ID Numbers: CGC03
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Rachel Watson, University of Manchester:
topical treatment
wrinkles
extracellular matrix