None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy adult females with age 21 to 50 years both inclusive at the time of consent. 2.Subjects with dry lips of grade 4 - 6 based on a 9-point visual dryness assessment scale. 3.Subjects with average size lips. 4.Subjects general in good health as determined from a recent medical history. 5.Subjects who have discontinued the use of all lip-enhancement products a minimum of three days prior to the baseline visit.
Exclusion criteria
Exclusion criteria: 1.Subjects with chronically dry or chapped lip conditions, which may not get improved with the use of lip-conditioning products. 2.Subjects with unevenly dark lips. 3.Subjects with a history of lip injections or lip surgery. 4.Chronic illness which may influence the cutaneous state. 5.Subjects receiving medications e.g., steroids or antihistamines would compromise the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of test product on lip moisture i.e., hydration state of the lip by MoistureMeterSCTimepoint: Day 01 [before application and after application at 4 hrs (plus 15 mins), 8 hrs (plus 15 mins)], Day 03 (plus 01 day) and Day 07 (plus 01 day) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess Subject Response Index (Perception about Product)Timepoint: Day 01 (30 mins (plus 10 mins) after application);To assess Subject Satisfaction Questionnaire after product usageTimepoint: Day 01 (30 mins (plus 10 mins), 4 hrs (plus 15 mins), 8 hrs (plus 15 mins) after application), Day 03 (plus 01 day) and Day 07 (plus 01 day);To assess the aesthetic improvement of lips by Dermatologist using Global Aesthetic Improvement Scale (GAIS)Timepoint: Day 01 [before application and after application at 30 mins (plus 10 mins) and 8 hrs (plus 15 mins)], Day 03 (plus 01 day) and Day 07 (plus 01 day);To assess the effect of test product on lip dryness by Dermatologist using 9-point visual dryness assessment scaleTimepoint: Day 01 [before application and after application at 30 mins (plus 10 mins), 4 hrs (plus 15 mins), 8 hrs (plus 15 mins)], Day 03 (plus 01 day) and Day 07 (plus 01 day);To assess the effect of test product on lip shine or gloss using Skin-Glossymeter GL 200Timepoint: Day 01 [before application and after application at 4hrs (plus 15 mins)];To assess the effect of test product on lip volume by Dermatologist using 5-point grading scaleTimepoint: Day 01 [before application and after application at 30 mins (plus 10 mins) and 4 hrs (plus 15 mins)];To assess the effect of test product on skin barrier function of lips by Transepidermal Water Loss (TEWL) using VapometerTimepoint: Day 01 [before application and after application at 4 hrs (plus 15 mins), 8 hrs (plus 15 mins)], Day 03 (plus 01 day) and Day 07 (plus 01 day);To evaluate the effect of test product on lip roughness using 3D Analysis System (Antera)Timepoint: Day 01 [before application and after application at 8 hrs (plus 15 mins)], Day 03 (plus 01 day) and Day 07 (plus 01 day) | — |
Countries
India
Contacts
Cliantha Research