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A clinical study to assess the safety and effectiveness of Moisturizing Lip Balm in Participants having cracked lips.

Clinical Study to assess the Safety and Efficacy of the Lip Balm in Participants with Dry and Chapped Lips: An Open-Label, Interventional, Prospective Study - HEAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/105458
Enrollment
30
Registered
2026-03-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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 Balm: Mode of Usage: Apply evenly onto the lips and massage gently. Frequency: Apply twice daily, especially after eating and drinking. Storage Condition: Store at room temperature

Sponsors

Relaner Ventures Pvt. Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age: 18 to 55 years at the time of consent. 2) Sex: Adult male and non-pregnant/non lactating female participants 3) Participants having dry, cracked and chapped lips. 4) Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of the screening visit. 5) Participant has not applied any lip balm or lipstick in the past 24 hours. 6) Participants must be willing and able to follow the study directions and to return for all specified visits with the product. 7) Participants must agree to record each use of the test products in the participant s diary card on daily basis.

Exclusion criteria

Exclusion criteria: 1) A known history or present condition of allergic response to any cosmetic products. 2) Participant having clinically active diseases of the lips, which will interfere with the test readings. 3) Participants with any skin condition on the lips, such as herpes. 4) Participants who are pregnant and/or breastfeeding. 5) Participants not willing to discontinue other topical lip products, such as other lip balms, lipsticks, lip liners & lip gloss throughout the study period. 6) Participant participated in any other cosmetic study in the past 4 weeks. 7) The participant is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data.

Design outcomes

Primary

MeasureTime frame
To evaluate the effectiveness of the test product in terms of change in hydration from baseline before usage and after usage of the test product.Timepoint: Post usage T20 min, T12 hours on Day 01, Day 07.

Secondary

MeasureTime frame
To evaluate the effectiveness of the test product in terms of change in lip surface roughness and smoothness from baseline before usage and after usage of the test product.Timepoint: Post usage T20 min, T12 hours on Day 01, Day 07.;To evaluate the effectiveness of the test product in terms of change in trans epidermal water loss (TEWL) of the lip surface from baseline before usage and after usage of the test product.Timepoint: Post usage T20 min, T12 hours on Day 01, Day 07.;To evaluate the effectiveness of test product in terms of reduction in pain and irritation associated with cracked lips from baseline before usage and after usage of the test product.Timepoint: Post usage T20 min, T12 hours on Day 01, Day 07.;To evaluate the effectiveness of test product in terms of change in visual appearance of the lips from baseline before usage and after usage of the test product.Timepoint: Post usage T20 min, T12 hours on Day 01, Day 07.;To evaluate the effectiveness of test product in terms of change in roughness, cracking and scaling from baseline before usage of test product and after usage of the test product.Timepoint: Post usage T20 min, T12 hours on Day 01, Day 07.;To evaluate the effectiveness of test product in terms of change in product perception questionnaire regarding moisturizing dry lips, soft lips, long lasting hydration from baseline before usage and after usage of test product.Timepoint: Post usage T20 min, T12 hours on Day 01, Day 07.

Countries

India

Contacts

Public ContactDr Maheshvari Patel

NovoBliss Research Private Limited

dr.nayan@novobliss.in07948983895

Outcome results

None listed

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