None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Voluntary men and women ratio of 1:1 between 18 and 65 years. 2. Having apparently healthy skin in test area as assessed by dermatological examination. 3. For whom the investigator considers that the compliance will be correct. 4. Subjects with normal, dry, oily and combination skin in approximately equal ratio. 5. The subject is informed of the need and duration of the examination and is ready to comply with protocol requirements. 6. Subject is ready to sign the informed consent form. 7. Subjects willingness to avoid intense UV exposure on test sites (sun or artificial UV) during the study. 8. Subjects willingness to avoid excessive water contact (e.g. swimming) or activity which causes excessive sweating (e.g. exercise, sauna) during the study. 9. Having valid proof of identity and age. 10. Volunteers evaluated Fitzpatrick skin type 3 to 5 as per the Fitzpatrick scale (Appendix IV).
Exclusion criteria
Exclusion criteria: 1. Pregnant/nursing mothers. 2. Scars, acne, excessive terminal hair, or tattoos on the studied area. 3. Dermatological infection/pathology on level of studied area. 4. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye) 5. Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures. 6. Chronic illness, which may influence the outcome of the study. 7. Subjects on any medical treatment, either systemic or topical, which may interfere with the performance of the study treatment (presently or in the past 1 month). 8. Subject in an exclusion period or participating in another food, cosmetic, or therapeutic trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change from irritation potential of the test products from baseline to post application measured using the mean irritation score. 2. Score of less than or equal to 2 on the Draize scale. Timepoint: Day 2, Day 3 and Day 9 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of treatment-emergent adverse events (safety and tolerability)Timepoint: Day 2, Day 3 and Day 9 | — |
Countries
India
Contacts
TrialGuna Private Limited