MedPath

Effectiveness of Plum Serum in skin blemishes

Phase 4
Registration Number
CTRI/2023/12/060475
Lead Sponsor
Pureplay Skin Sciences India Pvt Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Gender: Male or Female aged between 18 to 40, with minimum F:M distribution ratio of 2:1

2. Subject willing to give written informed consent

3. Women of child bearing potential must have a negative urine pregnancy test

4. Free of any systemic and dermatologic disorder, which in the opinion of the investigator, will interface with the study results or increase the risk of AE.

5. Are willing to avoid prolonged exposure of the

treatment area to ultraviolet radiation (natural orartificial) for the duration of the study.

Exclusion Criteria

1. Subjects who are pregnant, breastfeeding, or planning to become pregnant during the study

2. Have any evidence of systematic cancer, squamous cell carcinoma, basal cell carcinoma in the last 5 years, or any other confounding skin condition.

3. Have open sore or open lesions in the treatment area

4. Have any condition that, in the opinion of the

investigator would confound the safety and efficacy assessments of the product.

5. Have participated in any interventional clinical trial in the previous 30 days.

6. Have a known sensitivity to any of the constituents of the test product including sensitivities to any of the constituents.

7. Have used, are using, or are planning to use

immunosuppressive or immunomodulatory medications

(i.e., biologics), blood purifiers and including

corticosteroids.

8. Have a history of alcohol or illegal drug/ substance abuse or suspected alcohol or illegal drug/substance abuse in the past 2 years.

Study & Design

Study Type
PMS
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in SGA self-evaluation score blemishes, Smooth skin, open pores, customer satisfaction indexTimepoint: Day 0, Day 14 and Day 28
Secondary Outcome Measures
NameTimeMethod
Change in BlemishesTimepoint: Day 0, Day 14 and Day 28;Change in open poresTimepoint: Day 0, Day 14 and Day 28;Change in Skin colorTimepoint: Day 0, Day 14 and Day 28;Change in Skin GlossTimepoint: Day 0, Day 14 and Day 28;change in TEWLTimepoint: 0 min, 30 min;Skin in skin hydrationTimepoint: 0 min, 30 min
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