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A study to determine the safety and efficacy of Autologous Human Platelet Lysate (HPL) in treatment of Facial Wrinkles (Nasolabial Folds).

A Prospective, Multicentric, Open Label, Bio-Interventional, Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For Treatment of Facial Wrinkles (Nasolabial Folds)

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/05/002627
Enrollment
20
Registered
2012-05-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Facial Wrinkles (Nasolabial Folds)

Interventions

Intervention1: Autologous Human Platelet Lysate (HPL): Subjects will receive a single injection of Autologous Human Platelet Lysate (5mL) in the nasolabial region on Day 2 Intervention2: Autologous Hu

Sponsors

KASIAK RESEARCH PRIVATE LIMITED
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects (male and female), aged 18 to 40 years (both inclusive). 2. Subjects willing to refrain from any other treatment for Nasolabial Folds. 3. Subjects who are willing to give informed consent and adhere to the study protocol.

Exclusion criteria

Exclusion criteria: 1. Subjects receiving any aesthetic facial therapy 6 months prior to enrolment e.g. Botox, Fillers etc 2. Subjects with history of Connective tissue disease 3. Subjects with autoimmune diseases 4. Subjects unwilling to or unable to comply with the study protocol. 5. Subjects taking concomitant therapy that might interfere with the study results in the investigatorâ??s opinion or participating in another trial in the past 30days

Design outcomes

Primary

MeasureTime frame
â?¢ Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading at rest â?¢ Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading on full smile â?¢ Global Aesthetic Improvement Scale (GAIS ) Timepoint: End of Study - 3 Months

Secondary

MeasureTime frame
â?¢ Photographic Assessment â?¢ Physicianâ??s assessment scores â?¢ Patientâ??s assessment scores Timepoint: End of Study - 3 Months

Countries

India

Contacts

Public ContactDr Kaushal Shah

Dr Rachitas Skin Trichology & Aesthetic Centre

rachitadhurat@yahoo.co.in9870390057

Outcome results

None listed

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