PhotoagingNCT03144193
Efficacy in Daily Use of a Novel Skin Care Product for the Treatment of Photoaged Skin
A study testing Topical anti-aging cosmetic cream in people with Photoaging, run by University of Manchester at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Photoaging
- What is being tested?
- Topical anti-aging cosmetic cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2017to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Dermatopharmacology Unit, Salford Royal NHS Foundation Trust
Salford, M6 8HD
Jean Y Bastrilles, RCN, +441612064282, jean.bastrilles@manchester.ac.uk
Rachel E Watson, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Photoaging
- Being tested
- Topical anti-aging cosmetic cream
- Keywords
- topical treatment, wrinkles, extracellular matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical anti-aging cosmetic creamOther
Topical anti-aging cosmetic cream
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Topical anti-aging cosmetic cream (active) Receives: Other: Topical anti-aging cosmetic cream |
| Placebo | Placebo comparator | Basic formulation without active ingredients (vehicle) Receives: Other: Topical anti-aging cosmetic cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six (6) months
Secondary outcomes (2)
Histological improvement in skin structure
Histology to assess dermal elastic fibres and the collagenous extracellular matrix
Measured: Six (6) months
Tolerance and irritancy
Assessments will be made by recording the occurrence and severity of signs of erythema and scaling
Measured: Up to seven (7) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start1 Jun 2017 (estimated)
- Primary completion1 Dec 2017 (estimated)
- Study completion31 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PhotoagingStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assessment of efficacy of a novel anti-aging topical treatment compared to a placebo control
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Rachel Watson, University of Manchester
- Investigators
- Rachel E Watson, PhD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144193
- Sponsor's protocol ID
- CGC03
- Status last verified
- May 2017
- First submitted
- 27 Mar 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 10233772Watson 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.
PubMed 11348454Watson 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.
PubMed 18070204Griffiths 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.
PubMed 1550366
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy in Daily Use of a Novel Skin Care Product (CG Skin Ltd.) for the Treatment of Photoaged Skin
- ClinicalTrials.gov ID
- NCT03144193
- Acronym / sponsor ID
- CGC03
- Conditions
- Photoaging
- Keywords
- topical treatment, wrinkles, extracellular matrix
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Assessment of efficacy of a novel anti-aging topical treatment compared to a placebo control
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Topical anti-aging cosmetic creamTopical anti-aging cosmetic cream (active) |
| Placebo | Placebo comparator | Other: Topical anti-aging cosmetic creamBasic formulation without active ingredients (vehicle) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical anti-aging cosmetic creamTopical anti-aging cosmetic cream | Other | Experimental, Placebo |
Primary outcome
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.
2 secondary outcomes
Histological improvement in skin structure
Time frame: Six (6) months
Tolerance and irritancy
Time frame: Up to seven (7) months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Background: PubMed 10233772Watson 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.
- Background: PubMed 11348454Watson 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.
- Background: PubMed 18070204Watson 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.
- Background: PubMed 1550366Griffiths 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.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel E Watson, PhD principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical anti-aging cosmetic cream in people with Photoaging, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel E Watson, PhD (+441612755505, rachel.watson@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinical appearance using a validated photonumeric wrinkle scale (time frame: Six (6) months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03144193, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.