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Evaluation of the efficacy of an oral administration of new hyaluronan in improving skin aging signs in healthy adult women

Oral intake of new full spectrum hyaluronan improves skin profilometry and aging factors: a randomized, double-blind, placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15306510
Enrollment
60
Registered
2020-11-02
Start date
2020-09-23
Completion date
Unknown
Last updated
2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amelioration of the skin aging signs Skin and Connective Tissue Diseases Skin aging

Interventions

Participants will be enrolled following a dermatological visit, then assigned to one of the two groups of the study in a 1:1 ratio according to a restricted randomization list generated by using an ap

Sponsors

Complife Italia Srl
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Healthy female subjects, showing mild to moderate signs of skin aging 2. Aged between 35 and 70 years old 3. Caucasian ethnicity 4. Observed an adequate wash-out period from similar studies 5. Give informed consent 6. Agree not to make any changes to their normal everyday routine 7. Agree not to use products with comparable activity to the study product 8. Agree not to expose in an intensive way to UV rays during the whole study duration 9. Available to take food supplements and comply with the study protocol 10. Agree to adopt an adequate contraceptive system

Exclusion criteria

Exclusion criteria: 1. Eating disorders (such as bulimia and anorexia) 2. Pregnant, breastfeeding or have planned a pregnancy during the study period 3. Previous history of gastrointestinal pathological conditions 5. Systemic pharmacological treatment 6. Under local pharmacological treatment on the skin area monitored during the test 7. Congenital or acquired immunodeficiency 8. Under treatment with food supplements which could interfere with the functionality of the product being study 9. Other skin alterations on the monitored area 10. Exposed in intensive way to UV rays during the 4 weeks prior to the study start 11. Considered as not suitable to participate in the study by the investigator 12. Reported food intolerance to one or more ingredients contained in the food supplement 13. Alcohol addiction 14. Drug addiction

Design outcomes

Primary

MeasureTime frame
1. Determination of the Skin moisturization evaluated as skin moisturization index using a Corneometer® and trans epidermal water loss using a TEWAMETER® probe at baseline and 4 weeks 2. Determination of skin elasticity and firmness, based on the suction/elongation method and the subsequent release of skin using Cutometer® at baseline and 4 weeks 3. Determination of skin profilometry measuring wrinkle depth and wrinkle volume using Primos 3D at baseline and 4 weeks 4. Acquisition of face digital pictures using a reflex digital camera at baseline, 1, 2, 3, and 4 weeks 5. Evaluation of serum hyaluronic acid level in a subgroup of participants at baseline, 1, 2, 3, and 4 weeks

Secondary

MeasureTime frame
1. Products tolerability, efficacy, and acceptability evaluated using a self-assessment questionnaire at 4 weeks

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026