None listed
Conditions
Interventions
Intervention1: NIL: NIL
Sponsors
Sami-Sabinsa Group Ltd
Alkem Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male and female volunteers aged 18 to 65 with no active dermatological Conditions 2. Good general and mental health with, in the opinion of the investigator or medically qualified designee with no clinically significant and relevant abnormalities in medical history or upon physical examination 3. Subjects who have normal, dry, oily, combination (mixed) type of skin types. 4. Fitzpatrick photo type I to IV skin type 5. Willingness to participate as evidenced by voluntary written informed consent
Exclusion criteria
Exclusion criteria: 1. Healthy male and female volunteers aged 18 to 65 with no active dermatological Conditions 2. Good general and mental health with, in the opinion of the investigator or medically qualified designee with no clinically significant and relevant abnormalities in medical history or upon physical examination 3. Subjects who have normal, dry, oily, combination (mixed) type of skin types. 4. Fitzpatrick photo type I to IV skin type 5. Willingness to participate as evidenced by voluntary written informed consent Exclusion Criteria: 1. Women who are known to be pregnant or who are intending to become pregnant over the duration of the study 2. Women who are breast-feeding 3. Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction. 4. Presence of Acne, TLC more than 10 (Inflammatory & Non-Inflammatory). 5. Presence of Acne, TLC more than 10 (Inflammatory & Non-Inflammatory). 6. Considered immune compromised. 7. History of photosensitivity, & or diseases aggravated or triggered by ultraviolet radiation. 8. Participants with dermatographism. 9. Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk. 10. Use of the following topical or systemic medications: immunosuppressants, antihistamines, nonhormonal anti-inflammatory drugs, and corticosteroids up to 2 weeks before screening visit. 11. Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit 12. Intention of being vaccinated during the study period or vaccination within 3 weeks of the screening visit. 13. Currently receiving allergy injections, or due to receive an injection within 7 days prior to Visit1, or expects to begin injections during study participation 14. Previous history of atopic dermatitis, allergic reactions, irritation or intense discomfort feelings to topical use products, cosmetics, or medication. 15. Known or suspected intolerance or hypersensitivity to any of the study materials (or closely related compounds) or any of their stated ingredients including any component of the study product. 16. History of sensitization in a previous patch study 17. Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30days of the screening visit 18. Recent history (within the last years) of alcohol or other substance abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comedogensis: Upon completion of the above-described counting procedure, the ratio will be calculated as. Number of comedones/ Number of follicles. Timepoint: Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 16, Day 18, Day 20, Day 22, Day 24, Day 26, Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and severity of Adverse EventsTimepoint: Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 16, Day 18, Day 20, Day 22, Day 24, Day 26, Day 28 | — |
Countries
India
Contacts
Public ContactSatish G
Sami Sabinsa Group Ltd
Outcome results
None listed