To evaluate the efficacy of test products in Preventing Acne Flare ups and Associated Symptoms in Healthy Human Volunteers

Efficacy evaluation of Personal Care formulations in preventing acne and related symptoms in healthy human volunteers. - None

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/04/013491

Enrollment

Registered

2018-04-26

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

None listed

Interventions

Intervention1: Test Product â?? G-24: Dose:Approximately, 1.0g (Two squirts of the pump) of the provided investigational product is to be used to wash the face Frequency:Twice Daily Route of administr

Eligibility

Inclusion criteria

Inclusion criteria: 1.Volunteer in the age group of 18 to 35 years 2.Atleast 70 subjects with Oily / Acne prone skin 3.Atleast 10 subjects with Acne eruptions on the back 4.Atleast 10 subjects with Dry skin + Acne on face 5.Volunteer willing to participate in the study and provide signed informed consent for the same. 6.Volunteer willing to abide by the study protocol and refrain from using any product other than the provided Investigational product during the study course. 7.Volunteers willing to visit the site for periodic assessments on the scheduled dates. 8.Volunteer who exhibits good tolerance to the investigational product with no signs of sensitivity.

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women 2.Volunteer undergoing treatment for anti-acne or skin lightening 3.Volunteer with pre-existing systemic disease requiring long-term medication as disclosed by volunteers 4.Volunteer with genetic and endocrinal disorders as disclosed by volunteers 5.Volunteer with drug induced acne as disclosed by volunteers

Design outcomes

Primary

Measure	Time frame
1.No increase in Acne flare ups, skin irritation&skin dryness compared to baseline and benchmark at all studied timepoints as per Dermatologists assessment and Subjects assessment. 2.Significant reduction in skin redness / erythema, skin brightness, skin flakiness, comedons and skin oilyness compared to baseline at 1 week (T4), 2 weeks (T5), 4 weeks (T6) as per Dermatologists assessment and Subjects assessment at 95% significance level.Timepoint: Approximately 4 weeks	—

Measure

Time frame

1.No increase in Acne flare ups, skin irritation&skin dryness compared to baseline and benchmark at all studied timepoints as per Dermatologists assessment and Subjects assessment. 2.Significant reduction in skin redness / erythema, skin brightness, skin flakiness, comedons and skin oilyness compared to baseline at 1 week (T4), 2 weeks (T5), 4 weeks (T6) as per Dermatologists assessment and Subjects assessment at 95% significance level.Timepoint: Approximately 4 weeks

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Secondary

Measure	Time frame
1.Significant reduction in the number of lesions compared to baseline at the end of study at 95% significance level as per Dermatologists assessment and Subjects assessment. 2.Significant reduction in lesion size and severity compared to baseline at the end of study at 95% significance level as per Dermatologists assessment and Subjects assessment. 3.Significant reduction in skin pores compared to baseline at the end of study at 95% significance level as per Subjects assessment. Timepoint: Approximately 4 weeks	—

Measure

Time frame

1.Significant reduction in the number of lesions compared to baseline at the end of study at 95% significance level as per Dermatologists assessment and Subjects assessment. 2.Significant reduction in lesion size and severity compared to baseline at the end of study at 95% significance level as per Dermatologists assessment and Subjects assessment. 3.Significant reduction in skin pores compared to baseline at the end of study at 95% significance level as per Subjects assessment. Timepoint: Approximately 4 weeks

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Countries

India

Contacts

Public ContactDr Sapna R

MS Clinical Research Pvt Ltd

sapna.r@mscr.in08040917253

Outcome results