None listed
Conditions
Interventions
Intervention1: Ointment GTS122077,
Ointment GTS122078,
Ointment GTS122079,
Ointment GTS122080,
Ointment GTS122081,
Ointment GTS123446,
Ointment GTS123447 and
Ointment GTS123448
: Leave on Products,
D
Sponsors
The Procter Gamble Company
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and non-pregnant/non-lactating females between the ages of 18 and 65 at the time of consent. 2. Females of childbearing potential must have a negative urine pregnancy test performed on Day 1 prior to patch application. 3. In general good health as determined by the Medical and Dermatological History Questionnaire (Appendix A). 4. Able to read, understand and sign an informed consent agreement after being advised of the nature of the study. 5. Willing to refrain from using lotions, creams, powders or other skin preparations on the skin in the test area for the duration of the study. 6. Willing to refrain from exposing skin sites to the sun or going to tanning beds for the duration of the study. 7. Willing to refrain from swimming and using hot tubs for the duration of the study.
Exclusion criteria
Exclusion criteria: 1. Have a clinically significant active dermatitis or skin disease anywhere on the body (excluding facial acne). 2. Have a history of psoriasis, eczema or skin cancer. 3. Have a condition or are taking medication(s) which, in the judgment of the Investigator or Designate, makes the subject ineligible or places the subject at undue risk. 4. Have received treatment (chemotherapy, radiation, immune suppressant medications) for any type of cancer within the last 6 months. 5. Have had a mastectomy or axillary lymph nodes removed. 6. Have an autoimmune or immune deficiency disease (e.g. lupus, myositis, Crohns disease, autoimmune thyroid diseases, autoimmune hepatitis, etc.). 7. Are currently taking any immunosuppressant medication. 8. Have insulin-dependent diabetes. 9. Have asthma or any other chronic respiratory condition requiring daily therapy. 10. Are currently taking/using any antihistamines or systemic/topical anti-inflammatory medications (e.g. ibuprofen, corticosteroid, etc.) on a routine or frequent basis. Maximum acceptable dosage should be determined by written laboratory guidelines. 11. Have used a topical anti-inflammatory in the patch area within the last 2 weeks. 12. Are currently receiving allergy injections, expects to start injections before the conclusion of the study or has had the final injection within a week of the study start. 13. Are currently participating in another dermal study of any kind. 14. Are currently participating in any clinical study, which in the judgment of the Investigator, could potentially affect responses in either study. 15. Have a confirmed skin allergy as a result of participation in a patch study. 16. Have a known sensitivity or allergy relating to the substance(s) being evaluated. 17. Have a known sensitivity or allergy to adhesives, surgical tapes, bandages, etc. 18. Have scars, moles, sunburn, tattoos, etc. in the patch area.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessment of productsTimepoint: 20 - 40 minutes Irritation Scoring post patch removal Day 02, Day 03, Day 04, Day 05, Day 06, Day 07 and Day 08 | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactMs Maheshvari Tamboli
Cliantha Research
Outcome results
None listed