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72 hour moisturization study of Plum Oat & Allantoin All-day Nourishing Cream

Phase 4
Registration Number
CTRI/2023/11/059540
Lead Sponsor
Pureplay skin sciences
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 18 to 50

2) Subjects willing to give written informed

consent

3) Women of child bearing potential must have a negative urine pregnancy test prior to study entry.

4) Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study

results or increase the risk of adverse events.

5) Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of

the study.

Exclusion Criteria

1. Subjects who are pregnant, breast-feeding, or planning to become pregnant during the study.

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

3. Have open sores or open lesions in the treatment area(s).

4. Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of the product.

5. Have participated in any interventional clinical trial in the previous 90 days.

6. Have a known sensitivity to any of the constituents of the test product including sensitivities to Helianthus Annuus, Avena Sativa (Oat) Kernel, Argania Spinosa.

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

immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids.

8. Have not skin related issues

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
change in the moistureTimepoint: T0min, T+30 mins, T+ 2 hours, T+4 hours, T+ 8 <br/ ><br>hours, T+24 hours, T +48 hours, T + 72 hours
Secondary Outcome Measures
NameTimeMethod
Total Epidermal Water LossTimepoint: 0 Hr, 24 Hr, 48 Hr, 72 Hr
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