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

A prospective, open-label, 4 arm study to evaluate the safety and efficacy of Skin care product for its non-comedogenic effect in healthy male or female volunteers - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057974
Enrollment
60
Registered
2023-09-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Health Condition 1: L708- Other acne

Interventions

Intervention1: Hyphen Barrier Care Cream - Normal to Dry Skin: Dosage form: Semi Solid, Administration: Topical application, Direction for use: Press the pump until the bottle is activated. Take 2 to

Sponsors

Kreative Beauty Private Limited
Lead Sponsor

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. Mild to moderate Black heads on the face 4. Willing to complete the study assessments/questionnaires. 5. Willing to avoid usage of his/her own moisturizers and face 6. serum 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 tumors, 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

MeasureTime frame
•To assess the safety and efficacy of the product for its non-comedogenic property Following parameters will be evaluated: •Appearance of black heads •Improvementin Spotcorrection by improving the appearance of large pores Timepoint: Day 1 to Day 28

Secondary

MeasureTime frame
To evaluate the consumer acceptance as well as their response towards the product through a feedback questionnaire.Timepoint: Day 1 to Day 28

Countries

India

Contacts

Public ContactDr Ashok Godavarthi

Radiant Research Services Pvt. Ltd

surya.ashok@gmail.com9880999297

Outcome results

None listed

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