Status:
NOT_YET_RECRUITING
A Clinical Study to Assess the Safety and Effectiveness of Test Product in Healthy Adult Human Subjects With Dry or Sensitive Skin
Lead Sponsor:
SAVA Healthcare Limited
Conditions:
Dry Skin
Sensitive Skin
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
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.
Detailed Description
A total of up to 32 healthy male and non-pregnant \| non-lactating female with dry or sensitive skin and an age of 18-55 years will be enrolled to complete the 30 subjects of the study. The potential...
Eligibility Criteria
Inclusion
- 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.
- Subject with dry or sensitive skin at a time of screening. (Dermatological Assessment)
- Subjects assessment site must be free of cuts, tattoos, scratches, abrasions, scars, uneven skin tone, sunburn, excessive tan, excessive hair or open wounds.
- Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
- If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
- Subjects are willing to give written informed consent and are willing to come for regular follow up.
- Subjects who commit not to use medicated skincare products other than the test product for the entire duration of the study.
- Subject who have not participated in a similar investigation in the past three months.
- Willing to use test product throughout the study period.
Exclusion
- 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.
- Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.
- Subject having acne of severe incidence (presence of nodules, cysts or numerous pustules) which requires pharmaceutical or cosmeceuticals, herbal treatment.
- Subjects who have applied topical treatment for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study.
- History of alcohol or drug addiction.
- Subjects using other marketed products during the study period.
- Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion.
- Pregnant or breastfeeding or planning to become pregnant during the study period.
- History of chronic illness which may influence the cutaneous state.
- Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06929988
Start Date
May 15 2025
End Date
May 30 2025
Last Update
April 24 2025
Active Locations (1)
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1
NovoBliss Research Pvt.Ltd
Ahmedabad, Gujarat, India, 382421