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

NCT03144193 | Unknown

• 1 other identifier: CGC03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Photoaging

Keywords

topical treatment; wrinkles; extracellular matrix

Outcome Measures

Primary Outcomes (1)

• Change in clinical appearance using a validated photonumeric wrinkle scale

  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 Outcomes (2)

• Histological improvement in skin structure

  Six (6) months

• Tolerance and irritancy

  Up to seven (7) months

Study Arms (2)

Experimental

EXPERIMENTAL

Topical anti-aging cosmetic cream (active)

Other: Topical anti-aging cosmetic cream

Placebo

PLACEBO COMPARATOR

Basic formulation without active ingredients (vehicle)

Other: Topical anti-aging cosmetic cream

Interventions

Topical anti-aging cosmetic cream OTHER

Topical anti-aging cosmetic cream

Experimental; Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

Dermatopharmacology Unit, Salford Royal NHS Foundation Trust

Salford, M6 8HD, United Kingdom

Location

Related Publications (4)

• Watson RE, Griffiths CE, Craven NM, Shuttleworth CA, Kielty CM. Fibrillin-rich microfibrils are reduced in photoaged skin. Distribution at the dermal-epidermal junction. J Invest Dermatol. 1999 May;112(5):782-7. doi: 10.1046/j.1523-1747.1999.00562.x.

  PMID: 10233772 BACKGROUND

• Watson RE, Craven NM, Kang S, Jones CJ, Kielty CM, Griffiths CE. A short-term screening protocol, using fibrillin-1 as a reporter molecule, for photoaging repair agents. J Invest Dermatol. 2001 May;116(5):672-8. doi: 10.1046/j.1523-1747.2001.01322.x.

  PMID: 11348454 BACKGROUND

• Watson RE, Long SP, Bowden JJ, Bastrilles JY, Barton SP, Griffiths CE. Repair of photoaged dermal matrix by topical application of a cosmetic 'antiageing' product. Br J Dermatol. 2008 Mar;158(3):472-7. doi: 10.1111/j.1365-2133.2007.08364.x. Epub 2007 Dec 6.

  PMID: 18070204 BACKGROUND

• Griffiths CE, Wang TS, Hamilton TA, Voorhees JJ, Ellis CN. A photonumeric scale for the assessment of cutaneous photodamage. Arch Dermatol. 1992 Mar;128(3):347-51.

  PMID: 1550366 BACKGROUND

Study Officials

• Rachel E Watson, PhD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel E Watson, PhD

CONTACT

+441612755505; rachel.watson@manchester.ac.uk

Jean Y Bastrilles, RCN

CONTACT

+442064282; jean.bastrilles@manchester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader in Dermatology

Model Details: Assessment of efficacy of a novel anti-aging topical treatment compared to a placebo control

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: May 8, 2017
• Study Start: June 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: March 31, 2018
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

GB (1)