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

Completed

Conditions: Subjects of both sex (preferably with equal numbers) with age between 12 and 30 years (both inclusive at the time of consent/assent) having acne-prone skin and with mild to moderate acne.

Registration Number: CTRI/2023/10/058218

Lead Sponsor: Himalaya Wellness Company

Brief Summary: This is anopen label, non-randomized, single-arm clinical study to evaluate safety,in-use tolerability and efficacy of test products inhealthy human subjects with acne-prone skin and with mild to moderate acne.

The potentialsubjects will be screened as per the inclusion and exclusion criteria onlyafter obtaining written informed consent from the subjects.

All eligiblesubjects will undergo clinical evaluation by a Dermatologist, instrumentevaluation and subjective evaluation. Safety will be assessed throughout the study bymonitoring adverse events.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 102

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 (Î¼g/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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Assessment of acne severity (in terms of reducing acne) using Investigator global assessment (IGA) and counting of inflammatory and non-inflammatory lesions	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 Skin dryness using 5-point grading scale by Dermatologist	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 porphyrins using Visiopor	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 acne severity (in terms of preventing acne) using Investigator global assessment (IGA) and counting of inflammatory and non-inflammatory lesions	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 Skin redness using 5-point grading scale by Dermatologist	Day 01 (before application 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 Skin desquamation/flakiness using 5-point ordinal scale by Dermatologist	Day 01 (before application), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days)
Assessment of Subject Satisfaction Questionnaire after product usage	Day 01 (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 skin pigmentation using 9-point grading scale	Day 01 (before application), Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days)
Assessment of skin barrier function by measuring Transepidermal Water Loss (TEWL) using Vapometer	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 Product Response Index (Perception about Product) after product usage	Day 29 (plus 2 days)
Assessment of acne, erythema and acne marks/spots using 3D analysis system using Antera	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 skin sebum level using Sebumeter SM 815	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 skin moisturization using MoistureMeterSC	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)

Trial Locations

Locations (1): Cliantha Research
🇮🇳
Ahmadabad, GUJARAT, India
Cliantha Research
🇮🇳Ahmadabad, GUJARAT, India
Dr Parth Joshi
Principal investigator
8000085049
pjoshi@cliantha.com