Study to evaluate the safety and efficacy of Skin care product for its non comedogenic effect

A prospective, open-label, one arm study to evaluate the safety and efficacy of Efatop HYDRA GEL for its noncomedogenic effect in healthy male or female volunteers. - Non-comedogenic

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061563

Enrollment

Registered

2024-01-18

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

None listed

Interventions

Intervention1: Efatop HYDRA GEL: Dosage form: Semi Solid, Administration: Topical application, Direction for use: Apply on face twice a day Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy Indian male/female healthy volunteers aged between 18-55 years. 2.Willing to give Informed Consent Form. 3.Subjects with Clear to mild skin condition according to GAGS score 0 to 2. 4.Willing to complete the study assessments/questionnaires. 5.Willing to avoid usage of his/her own skin care products for at least one week before Commencement and during this study.

Exclusion criteria

Exclusion criteria: 1.Pregnancy or breast feeding. 2.Patients with pre-existing severe systemic disease necessitating long-term medication. 3.Patients with mild to severe Anaphylaxis reactions. 4.Evidence of significant uncontrolled co-morbid disease. 5.History of cancer, including solid tumours, hematologic malignancies and carcinoma in situ 6.Any neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments. 7.Participation in the current or previous clinical trial with any approved or investigational products during the past 1 month.

Design outcomes

Primary

Measure	Time frame
• To assess the safety and efficacy of skin care product for its non-comedogenic property. Following parameters will be evaluated: • Appearance of black heads through Videoscopy. • Assessments of blocked pores through pore indicator test. Timepoint: Day 0 to Day 30	—

Secondary

Measure	Time frame
• To evaluate the consumer acceptance as well as their response towards the product through a feedback questionnaire.Timepoint: Day 0 to Day 30	—

Countries

India

Contacts

Public ContactDr Ashok Godavarthi

Radiant Research Services Pvt. Ltd

surya.ashok@gmail.com9880999297

Outcome results