Acne Skin and Connective Tissue Diseases
Conditions
Interventions
A double-blind, randomized, placebo/reference product-controlled clinical study was carried out on eighty subjects of both sexes, enrolled by a dermatologist according to specific inclusion/exclusion
subjects were equally divided in the following 4 groups according to a randomization list previously generated using an appropriate statistic algorithm (“Wey’s urn”):
- Group 1 (G1):
Sponsors
Complife Italia Srl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Good general health 2. Both sexes, caucasian ethnicity 3. Phototype I to IV 4. Age between 18 and 50 years old 5. Acne severity from 1 to 3 according to IGA, (Investigator’s Global Assessment) severity scale, 6. Subjects who have not been recently involved in any other similar study 7. Willingness to use for face care only the creams that will be consigned at the beginning of the study 8. Willingness to submit before and after pictures 9. Willingness to use during all the study period only the products to be tested 10. Willingness not to use similar products that could interfere with the product to be tested 11. Willingness to not vary the normal daily routine (i.e. lifestyle, physical activity, etc.) 12. Subject is under effective contraception (oral/not oral); not expected to be changed during the trial 13. Subject aware of the study procedures and having signed an informed consent form 14. Subjects who accept not to expose in an intensive way to UV rays during the whole study duration
Exclusion criteria
Exclusion criteria: 1. Subjects who do not meet the inclusion criteria 2. Pregnant/breastfeeding female or who have planned pregnancy during the study period 3. Subjects under systemically pharmacological treatment 4. Subjects under locally pharmacological treatment on the skin area monitored during the test 5. Subjects with congenital or acquired immunodeficiency 6. Subjects under treatment with food supplements which could interfere with the functionality of the product under study 7. Subjects who show other skin alterations on the monitored area 8. Subjects considered as not adequate to participate in the study by the investigator 9. Subjects with known or suspected sensitization to one or more test formulation ingredients 10. Adult protected by law (under control or hospitalized in public or private institutions for reasons other than research, or incarcerated) 11. Subjects not able to communicate or cooperate with the investigator for problems related to language, mental retardation, or impaired brain function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sebum levels, measured by using the Sebumeter® method (Sebumeter 815, Courage+Khazaka GmbH) at t=0, T28 and T56. 2. Skin pH measured by SKIN pH-METER 905® (Courage + Khazaka GmbH)at t=0, T28 and T56. 3. Skin moisturization, measured by the Corneometer® method (Corneometer® CM 825 (Courage+Khazaka, electronic GmbH)at t=0, T28 and T56. 4. Dermatological assessment of facial skin by countin acne lesions at t=0, T28 and T56 5. Evaluation of skin inflammatory status through face digital pictures at t=0, T28 and T56. | — |
Secondary
| Measure | Time frame |
|---|---|
| Products tolerability, efficacy, and acceptability were evaluated in a discussion with the dermatologist at the end of the treatment. | — |
Countries
Italy
Outcome results
None listed