Skin with moderate signs of aging Skin and Connective Tissue Diseases
Conditions
Interventions
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.
Effic
Sponsors
ISDIN S.A
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States of America
Contacts
Public ContactJavier Bustos
Outcome results
None listed