Dermatological Safety and Skin Compatibility Evaluation of Test Products

NCT07195851 | Not Yet Recruiting

• 1 other identifier: NB250039-OL
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

Dermatological Safety and Skin Compatibility Evaluation of Test Product following Cosmetics Europe: Product Test Guidelines for Assessment of Human Skin Compatibility (Colipa Standard, 1997)

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• To evaluate the dermatological safety of the test products assessed by 48-hour patch test under complete occlusion condition.

  Dermatological reactions will be evaluated using the 48-hour patch test method under complete occlusion. Assessments will be performed to detect any skin irritation, erythema, or other local reactions at the application site.

  30 ± 5 minutes post patch removal (Day 03), 24 ± 2 hours post patch removal (Day 04), and 48 ± 2 hours post patch removal (Day 05).

Secondary Outcomes (1)

• Skin Safety Evaluation by assessing Change in Transepidermal Water Loss (TEWL) at the Application Site

  at baseline, 30 mins and 24 hours post patch removal

Study Arms (1)

Single Arm includes 4 test products along with positive and negative control

EXPERIMENTAL

Below interventions along with 1% SLS (Positive control) and 0.9% Normal saline (Negative Control) will be applied in subject's forearm 1. Bare Anatomy Expert Advanced Hair Growth Serum 2. Bare Anatomy Expert Ultra-Smoothing Shampoo 3. Bare Anatomy Expert Ultra-Smoothing Hair Serum 4. Bare Anatomy Expert Ultra-Smoothing Hair Mask

Other: 1.Bare Anatomy Expert Advanced Hair Growth Serum 2.Bare Anatomy Expert Ultra-Smoothing Shampoo 3.Bare Anatomy Expert Ultra-Smoothing Hair Serum 4.Bare Anatomy Expert Ultra-Smoothing Hair Mask

Interventions

1.Bare Anatomy Expert Advanced Hair Growth Serum 2.Bare Anatomy Expert Ultra-Smoothing Shampoo 3.Bare Anatomy Expert Ultra-Smoothing Hair Serum 4.Bare Anatomy Expert Ultra-Smoothing Hair Mask OTHER

Dose: 0.1 ml of sample solution Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 48 hours.

Single Arm includes 4 test products along with positive and negative control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-65 years (both inclusive) at the time of consent.
• Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
• Subject with normal Fitzpatrick skin type III to VI (Human skin colour determination scale).
• Females of childbearing potential must have a self-reported negative pregnancy test.
• Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
• Subject is in good general health as determined by the Investigator on the basis of medical history.
• Subjects is willing to maintain the test patches in designated positions for 24 Hours.
• Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
• Subject must be able to understand and provide written informed consent to participate in the study.
• Subject is willing to refrain from vigorous physical exercise during the study period and follow all the instruction given.
• For Sensitive Specific Skin Study Only:
• Subject scoring greater than 30 for Section 2 - Sensitive v/s Resistant skin in modified Dr Baumann's skin type questionnaire.
• Subject with sensitive skin as confirmed by Lactic Acid stinging test.

You may not qualify if:

• Subject having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos (within the previous 3 months), scars, sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that can interfere with the reading.
• Medication which may affect skin response and/or past medical history.
• Subject having history of diabetes
• Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
• Subject suffering from any active clinically significant skin diseases which may contraindicate.
• Subject having history of any skin diseases including eczema, atopic dermatitis or active cancer.
• Participation in any patch test for irritation or sensitization within the last four weeks.
• Subject having history of asthma or COPD (Chronic obstructive pulmonary disease).
• Use of any:
• i. Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to application. ii. Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application. iii. Systemic or topical corticosteroids at patch site within four (4) weeks of test product application (steroidal nose drops and/or eye drops are permitted)
• Topical drugs used at application site.
• Subject with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematous.
• Individual who has a medical condition or is taking or has taken a medication which, in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk.
• Subject with known allergy or sensitization to medical adhesives, bandages.
• Participation in other patch study simultaneously.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• OneSto Labs Private Ltd.: collaborator

Study Officials

• Dr. Nayan Patel

  NovoBliss Research Private Limited

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maheshvari N Patel

CONTACT

919909013236; maheshvari@novobliss.in

Sheetal Khandwala

CONTACT

bd@novobliss.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will receive test products patches on the forearm, including the test product(s), a negative control (0.9% Saline), and a positive control (1% sodium lauryl sulfate).

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 29, 2025
• Study Start: September 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share