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Clinical of injectable filler Stylux Lip in increasing the volume of lips

Clinical evaluation of safety and effectiveness of injectable filler Stylux Lip made by Novajen Daru Co. in increasing the volume of lips

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190210042676N35
Enrollment
20
Registered
2024-11-28
Start date
2024-12-05
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Lips area. Changes in skin texture

Interventions

Intervention group: One treatment session on both lips according to the physician diagnosis, with maximum 1 ml injectable gel with the Stylux Lip brand made by Novajen Daru Co. using the retrograde m

Sponsors

Novajen Daru
Lead Sponsor

Eligibility

Sex/Gender
All
Age
21 Years to 65 Years

Inclusion criteria

Inclusion criteria: 21 -65 years old men and women 1 to 3 lips Prominence based on MLFS criteria. The opportunity to accompany the visit programs and study process Signing the informed consent form and agree to a 6-month follow-up.

Exclusion criteria

Exclusion criteria: Previous hyaluronic acid (HA)-based lips filler treatment injected within the last year History of previous allergy to ingredients of gel or protein of gram-positive bacteria Abnormalities in the lips area, such as sugary lips and etc.. Any inflammation, active infection, old unhealed scars and skin lesions in the lips area

Design outcomes

Primary

MeasureTime frame
Percentage of people with one grade or more improvement in MLFS(Medicis Lip Fullness Scale) scale. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Scoring lips volume using digital photos based on MLFS (Medicis Lip Fullness Scale).

Secondary

MeasureTime frame
Percentage of people with one grade or more improvement in MLFS scale. Timepoint: Before intervention, 3 and 6 weeks after intervention. Method of measurement: Scoring lips volume using digital photos based on MLFS (Medicis Lip Fullness Scale).;Patient satisfaction from treatment. Timepoint: 2 weeks, 3 and 6 months after intervention. Method of measurement: Using the VAS scale (visual analogue scale) from 0-10 so that 10 is a sign of complete satisfaction and 0 is complete dissatisfaction.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAniseh Samadi

Tehran University of Medical Sciences

aniseh_samadi@yahoo.com+98 21 8896 0880

Outcome results

None listed

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