A Clinical Study to Assess the Safety and Effectiveness of Test Product in Healthy Adult Human Subjects With Dry or Sensitive Skin

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorSAVA Healthcare Limited

About this trial

This exploratory, prospective, open-label, single-centre, safety, efficacy and in-use tolerability study of the test product in healthy adult human subjects with dry or sensitive skin.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: 18 to 55 years (both inclusive) at the time of consent.

Sex: Healthy male and non-pregnant/non-lactating females.

Females of childbearing potential must have a self-reported negative pregnancy test.

Subject are generally in good health.

Disqualifiers

History of any dermatological condition of the skin diseases.

Subject with present condition of allergic response to any cosmetic product.

Subject having allergic response to the ink.

Presence of any broken, chapped, cut, irritated, or scraped skin at the application site.

Trial design

Design model

Single group

Treatments tested in this trial

  • Creanz Lotion

    Other intervention

    Mode of Usage: Apply sufficient quantity of Creanz Nourishing Body lotion to face and body for smooth and moisturised skin. Frequency: Twice a Day Route of Administration: Topical

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Creanz LotionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in skin hydration

Instrumental Assessment: Corneometer CM 825

Time frame
baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
2

Change in skin elasticity

Instrumental Assessment: Cutometer Dual MPA 580

Time frame
Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
3

Change in Dry skin area and severity index

Dermatological assessment: 0 = Absent; 4 = Severe

Time frame
Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
4

Change in Overall Dry skin Score

Dermatological assessment: 0 = Absent; 4 = Dominated by large scales

Time frame
Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)

Secondary outcomes

1

Change in itchiness score

Dermatological Assessment: VAS score 0= no itch,10 = severe itch

Time frame
Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
2

change in visual assessment of skin dryness,

Dermatological Assessment: 0= absent,4 = Extreme

Time frame
Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
3

Change in visual assessment of skin smoothness,

Dermatological Assessment: 0= absent,4 = severe

Time frame
Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
4

Change in visual assessment of skin roughness,

Dermatological Assessment: 0= absent,4 = extreme

Time frame
Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)

Other outcomes

Sponsors and contacts

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