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Safety and Efficacy of lip oil on female subjects with dry lips.

An open label, single-arm, single center clinical study to evaluate the safety, in-use tolerability and efficacy of lip oil on female subjects with dry lips. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/12/060694
Enrollment
60
Registered
2023-12-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Lip Oil: Cleanse lips to remove any residue or lip products. Then, generously apply the lip oil, ensuring complete coverage of both lips. Repeat application after every 4-6 hrs. Product

Sponsors

DPKA Universal Consumer Ventures Private Limited
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactDr Simran Sethi

Cliantha Research

pjoshi@cliantha.com8000085049

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026