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A study to evaluate the Safety, In-Use Tolerability and Efficacy of a test product in reducing acne and acne spots on the face.

A clinical study to evaluate Safety, In-Use Tolerability and Efficacy of HARF-042202 in healthy adults with mild to moderate acne and acne prone skin. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/058218
Enrollment
102
Registered
2023-10-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

None listed

Interventions

Intervention1: HARF-042202: Moisten the face and apply approximately 3ml of test product. Lather will be gently worked up using a circular motion. Rinse the Face thoroughly and pat dry. Use the produc

Sponsors

Himalaya Wellness Company
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Subjects having good general health as determined by the Investigator on the basis of medical history. Subjects with acne-prone skin and with mild to moderate acne condition as per IGA scale and acne prone skin. 2) Subjects with oily skin having Sebumeter measurement > 180 (µg/cm2). 3) Female subjects of childbearing potential must have a negative urine pregnancy test performed on screening and enrolment visit. 4) Subjects who are not under any dermatologic treatment for acne and scar/ prescribed medications.

Exclusion criteria

Exclusion criteria: 1) Subjects with drug induced acne as disclosed by subjects. 2) Subjects undergoing treatment for skin lightening or subjects using other marketed skin lightening products during the study period or in the past 6 weeks. 3) Subjects who are receiving topical or systemic treatments for acne or acne marks. 4) Subjects receiving medications (e.g., steroids or anti-histamines) which would compromise the study.

Design outcomes

Primary

MeasureTime frame
Assessment of acne severity (in terms of reducing acne) using Investigator global assessment (IGA) and counting of inflammatory and non-inflammatory lesions.Timepoint: Day 01 (before application to Day 29 (plus 2 days)

Secondary

MeasureTime frame
Assessment of skin moisturization using MoistureMeterSCTimepoint: Day 01 (before application, 30 mins, and 8 hours post product application), Day 02 (24 hr. post application), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days);Assessment of acne severity (in terms of preventing acne) using Investigator global assessment (IGA) and counting of inflammatory and non-inflammatory lesionsTimepoint: Day 01 (before application), Day 02 (24 hr. post application), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) Day 29 (plus 2 days);Assessment of acne severity (in terms of reducing acne) using Investigator global assessment (IGA) and counting of inflammatory and non-inflammatory lesionsTimepoint: Day 01 (before application), Day 02 (24 hr. post application), Day 03, Day 08 (plus 2 days) and Day 15 (plus 2 days);Assessment of acne, erythema and acne marks/spots using 3D analysis system using AnteraTimepoint: Day 01 before application and 8 hours post application, Day 02 (24 hr), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days);Assessment of porphyrins using VisioporTimepoint: Day 01 (before application), Day 02, (24 hr. post application), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days);Assessment of Product Response Index (Perception about Product) after product usageTimepoint: Day 29 (plus 2 days);Assessment of skin barrier function by measuring Transepidermal Water Loss (TEWL) using VapometerTimepoint: Day 01 (before application), Day 02 (24 hr. post application), Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days);Assessment of Skin desquamation/flakiness using 5-point ordinal scale by DermatologistTimepoint: Day 01 (before application), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days);Assessment of Skin dryness using 5-point grading scale by DermatologistTimepoint: Day 01 (before application), Day 02 (24 hr. post application), Day 03, Day 08 (plus 2

Countries

India

Contacts

Public ContactDr Simran Sethi

Cliantha Research

pjoshi@cliantha.com8000085049

Outcome results

None listed

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