The evaluation of the effect and safety of night serum in visible signs of aging
| ISRCTN | ISRCTN33018063 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33018063 |
| Secondary identifying numbers | ISD-AE652-01-2018 |
- Submission date
- 31/10/2019
- Registration date
- 05/11/2019
- Last edited
- 04/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Background and study aims
The skin loses its structure and functionality as we age. This is caused by different factors like metabolic aging and oxidative stress caused by UV light and pollution. A night serum contains antioxidants and ingredient that improves skin's elasticity and firmness. The aim of this study is to evaluate the anti-aging effect of the night serum in the improvement of the clinical signs of skin/facial aging.
Who can participate?
Healthy volunteers (men and women), aged between 40 and 75 years old with moderate skin aging
What does the study involve?
Participants use the serum every night for 12 or 24 weeks (depends on the site) on the face, neck and neckline. Doctors evaluate their skin before and after (at 6, 12, 18 and 24 weeks) the use of the product and take photographs of the face. Participants are also asked to evaluate their skin condition and quality of life at the same timepoints. Participants in the biopsy study have biopsies (samples) taken from the forearm (at site 1) or from the neck (at site 2).
What are the possible benefits and risks of participating?
The potential benefit of participating is an improvement in the appearance of the face, neck and neckline. The potential risk is discomfort on the skin. For participants having biopsies potential risks are the ones related to this kind of procedure.
Where is the study run from?
1. Skin Laser & Surgery Specialists, Hackensack, NJ (USA)
2. Modern Dermatology, Westport, CT (USA)
When is the study starting and how long is it expected to run for?
June 2018 to July 2019
Who is funding the study?
ISDIN
Who is the main contact?
Javier Bustos
javier.bustos@isdin.com
Contact information
Mr Javier Bustos
Public
Public
ISDIN S.A.
Provençals 33
Barcelona
08019
Spain
| Phone | +34 (0)932402020 |
|---|---|
| javier.bustos@isdin.com |
Study information
| Study design | Multicentre prospective open-label trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Multicenter, open-label, clinical study evaluating the efficacy and safety of an antiaging night serum product applied once daily for improvement of visible aging signs in healthy subjects with moderate facial aging |
| Study objectives | The aim of this study was to evaluate the anti-aging efficacy of the serum containing melatonin, bakuchiol and vitamin C with other ingredients that provide deep nourishment. |
| Ethics approval(s) | 1. Approved 05/07/2018, Allendale Investigational Review Board (30 Neck Road, Old Lyme, CT 06371, USA; Tel: +1 (0) 860 434 5872) 2. Approved 09/10/2018, U.S. Investigational Review Board Inc (6400 SW 72 Court, Miami, Florida 33143, USA; Tel: +1 (0)786 473 3095), ref: U.S.IRB2018MD/01 |
| Health condition(s) or problem(s) studied | Skin with moderate signs of aging |
| Intervention | Subjects were instructed to use the serum once a day at night on the face, neck and neckline for 12 weeks. On site n#2 subjects participated in an extension period to 24 weeks. Efficacy assessments were conducted on week 6, 12, 18 and 24 (standardized photos, expert investigator grading, subjects reported outcome measures). Skin biopsies were collected from the arms (treated and untreated arm) at baseline and Week 12 at site#1 and the neck (baseline and treated sun-exposed area) at baseline and Week 24 at site#2. |
| Intervention type | Other |
| Primary outcome measure | Signs of aging considering separately each sign graded by the investigators scale (radiance, skin texture/smoothness, pigmentation, erythema, pore size, skin tone, skin complexion, lines, wrinkles and youthful appearance) at baseline, Week 6, Week 12, Week 18 and Week 24 |
| Secondary outcome measures | 1. Change in overall fine lines, wrinkles, hyperpigmentation and erythema measured using Investigator Global Aesthetic Improvement Scale (GAIS) evaluated by investigator at baseline, Week 6, Week 12, Week 18 and Week 24 2. Change in radiance, skin texture/smoothness, pigmentation, erythema, pore size, skin tone, skin complexion, lines, wrinkles and youthful appearance measured using Skin Quality Assessments scale evaluated by investigator at baseline, Week 6, Week 12, Week 18 and Week 24 3. Photodamage and hyperpigmentation measured using the Investigator Global Assessment (IGA) scale evaluated by investigator at baseline, Week 6, Week 12, Week 18 and Week 24 4. Change in signs of facial aging measured using Wrinkle Severity Scale evaluated by investigator at baseline, Week 6, Week 12, Week 18 and Week 24 5. Change in overall fine lines, wrinkles, hyperpigmentation and erythema measured using Subject Global Aesthetic Improvement Scale (SGAIS) evaluated by subject at baseline, Week 6, Week 12, Week 18 and Week 24 6. Change in lines/wrinkles, spots, redness, firmness, radiance/luminosity and skin texture/smoothness measured using Standardized digital images captured with VISIA or standardized system evaluated at baseline, Week 6, Week 12, Week 18 and Week 24 7. Local (dermal) tolerability examination on investigational areas including assessments of stinging/burning (rated by the subject), dryness, scaling, edema and erythema (rated by the investigator). It will be evaluated by grading from 0 (None) to 3 (Severe) at all study visits 8. Adverse events, including the seriousness, grade and causal relationship with IP as per adverse event standard criteria, recorded in the CRF on Week 6, Week 12, Week 18 and Week 24 |
| Overall study start date | 07/06/2018 |
| Completion date | 11/07/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 24 |
| Key inclusion criteria | 1. Healthy females and males who are regular users of serum products 2. Age: between 40 and 75 years old inclusive at enrollment 3. Subjects with moderate skin aging 4. Subjects with Fitzpatrick photo skin types I-V 5. Subjects will be able to read, understand and sign an informed consent form 6. Willing to be photographed and sign photograph (model) release form 7. Subject willing to adhere to the protocol and study procedures 8. Subjects who agree not to have any procedures affecting facial wrinkles or skin quality (Ex. microdermabrasion, peels, acne treatments, filler, botulinum toxin, radiofrequency, laser, IPL, ultrasound) for the duration of the study 9. Subjects try to follow a daily facial routine 10. Subjects are willing and able to follow all study assessments, attend study visits as scheduled and must be willing to accept the restrictions of the study, including but not limited to: 10.1. Arrive at each visit with clean facial skin, having cleansed within one hour of the study visit and having applied no topical products 10.2. Refrain from using self-tanning products on the face and body for the duration of the study 10.3. Refrain from excessive sun exposure or artificial UV tanning for any purpose for the duration of the study 10.4. Fotoprotector 50+ must be used in case of sun exposure |
| Key exclusion criteria | 1. Subjects having an acute or chronic disease or medical condition, including dermatological problems, which could put them at risk in the opinion of the Principal Investigator or compromise study outcomes 2. Subjects who are unreliable or unlikely to be available for the duration of the study 3. Subjects with a history of allergic reactions, skin sensitization and/or known allergies to cosmetic ingredients, toiletries, sunscreens, etc 4. Immunocompromised subjects 5. Subjects who started Hormone Replacement Therapy within the last three months preceding the screening visit 6. Subjects using oral contraception for less than 3 months before the screening visit or who has changed contraceptive method within the 3 months before the Baseline visit or planning to modify contraception treatment within the duration of the study 7. Subjects who are pregnant, breastfeeding or planning to become pregnant within 6 months 8. Subjects who have been treated with botulinum toxin in the face in the past 6 months 9. Subjects who have had treatments with hyaluronic acid, CaHA or poly-L-lactic acid fillers in the face in the last 24 months 10. Subjects who have had treatments with PMMA or any permanent filler in the face at any time 11. Subjects who have had a surgical procedure of the face, including face lift, blepharoplasty, etc. at any time 12. Subjects who have had any kind of facial dermabrasion, chemical peel, laser, IPL or any other treatment that could influence the skin quality in the past 3 months or for the duration of the study 13. Subjects who have had systemic corticosteroid therapy or any other therapy with influence on the skin quality in the past 6 months or for the duration of the study 14. Subjects who have used a topical, retinoid, retinol, or retinol derivative or topical antioxidant within the last 30 days 15. Subjects who does not agree to avoid using tanning beds or intensive exposure to the sun for the duration of the study and within two weeks of initiating participation 16. Subjects who have participated in another research study in the past 15 days 17. Individuals unable to communicate or cooperate with the Principal Investigator due to any reason deemed by the PI 18. Patients with marked photodamage with apparent precancerous or cancerous lesions 19. Patients unwilling to stop other topical facial products, with the exception of sunscreen, for the duration of the study, except as those defined that may be used |
| Date of first enrolment | 02/08/2018 |
| Date of final enrolment | 17/01/2019 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Skin Laser & Surgery Specialists
20 Prospect Ave #702
Hackensack
NJ 07601
United States of America
Hackensack
NJ 07601
United States of America
Sponsor information
ISDIN S.A
Industry
Industry
Provençals 33
Barcelona
08019
Spain
| Phone | +34 (0)932402020 |
|---|---|
| javier.bustos@isdin.com | |
"ROR" |
https://ror.org/04dg86p75 |
Funders
Funder type
Industry
ISDIN S.A.
No information available
Results and Publications
| Intention to publish date | 15/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | The researchers intend to publish the study results in an international peer-reviewed indexed scientific journal. Additional documents are not published online. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. Written informed consent from participants was obtained. |
Editorial Notes
04/11/2019: Trial's existence confirmed by Investigational Review Board.
