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Clinical Trials/CTRI/2025/01/079167
CTRI/2025/01/079167CompletedNot Applicable

To evaluate and compare the in-vivo safety and efficacy of Skin Care Formulation verses Untreated Control in terms of skin moisturization and skin barrier function on healthy female subjects

Alembic Pharmaceuticals Ltd.1 site in 1 country33 target enrollmentStarted: February 1, 2025Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
33
Locations
1
Primary Endpoint
skin moisturization and skin barrier function
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

OBJECTIVE 

The objective of this study will be to evaluate and compare the in-vivo safety and efficacy of Skin Care Formulation verses Untreated Control in terms of skin moisturization and skin barrier function on healthy female subjects for product.

Test Product: Oryza Acne Cream: Product A

Techniques: The evaluation is performed using: 1) Subject Self Evaluation, 2) Dermatological Evaluation: Safety, 3) Corneometry and 4) Tewametry

Total duration of the study: 72 hours following the first application of the product.

Kinetics: T0, T+30 Minutes, T+24 hours, T+48 hours & T+72 Hours after product application

POPULATION: 33 female subjects will be selected for the study.

The subjects selected for this study are healthy female subject, aged between 18 and 40 years old, having dry skin on forearms

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •1.Indian female subjects 2.Healthy subjects 3.Skin is healthy on the studied anatomic unit 4.Subject having dry skin on forearms.

Exclusion Criteria

  • •Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
  • •Having refused to give his/her assent by not signing the consent form and Informed consent form
  • •Taking part in another study liable to interfere with this study
  • •Being known diabetic case
  • •Known asthma case
  • •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
  • •Being known thyroid case
  • •Being epileptic.
  • •Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes or corticosteroid by any route (the only medication permitted is paracetamol)
  • •Known case of hypersensitivity.
  • •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
  • •Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
  • •Having changed their cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit.
  • •Having applied a cosmetic product (included make-up) on the studied areas 48 hours prior study. Refusing to follow the restrictions below during the study:
  • •Do not take part in any family planning activities leading to pregnancy and breastfeeding.
  • •Do not take part in another study liable to interfere with this study.
  • •Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
  • •Do not change her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit
  • •During the study: Do not use other cosmetic products than the tested products to the studied areas. Specific criteria
  • •Having started, changed, or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy, thyroid…) in the past 3 months.
  • •Having taken an oral retinoid-based treatment in the past 6 months
  • •Having taken a local retinoid-based treatment on the studied areas in the previous month
  • •Having had beauty treatment (e.g. scrub, manicure, self-tanning product …) in the previous week
  • •Having practiced water activities (swimming pool, sauna, hammam, baleneotherapy etc.) in the previous week.
  • •Having practiced water activities (swimming pool, sauna, hammam, baleneotherapy etc.) in the previous week
  • •Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements
  • •Having practiced intensive sports during the day prior to the T0 measurements
  • •Having wounds, Scars, sunburns, tattoos and piercing on test site.
  • •Having hair on test site.
  • •Having applied another product than water on the studied areas in the morning of the T0 measurements
  • •Having had an intensive UV exposition on the inner forearm (solariums, sun) prior to T0 measurements.
  • •Having used moisturizing products on the arms during 24 hours prior to T0 measurements. Refusing to follow the restrictions below during the study: • Do not have beauty treatment (e.g. scrub, manicure self-tanning product …) • Do not practice water activities (swimming pool, sauna, hammam, balneotherapy etc.) • Do not drink/ eat caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food, nor smoke.
  • •Do not practice sport • Do not apply any product on inner forearm including water. • Do not wipe their forearm. • Do not wear jewels on the wrists. • Do not have an intensive UV exposition on the arms (solariums, sun). Between T0 and T+72 hours measurements: • Do not use skin care products on the inner forearms.
  • •• Do not wash the inner forearms. • Do not use Surfactant containing product on the test sites. • Daily morning hygiene with water accepted except on inner forearms.

Outcomes

Primary Outcomes

skin moisturization and skin barrier function

Time Frame: T0, 30 Minutes, 24 hours, 48 hours & 72 Hours after product application

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Pharmaceutical industry-Indian
Responsible Party
Principal Investigator
Principal Investigator

Dr Pooja Yadav

MASCOT-SPINCONTROL India Pvt. Ltd.

Study Sites (1)

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