A Clinical Study to determine Safety, Efficacy, In-Use Tolerability Study of HDSC-022209.

Completed

Conditions: 18 to 55 years old healthy subject with facial dark spot

Registration Number: CTRI/2023/03/050239

Lead Sponsor: Himalaya Wellness Company

Brief Summary: This study is designed as an -open label, single arm, single-center, efficacy, safety, skin compatibility, and in-use tolerability stdy of HDSC-022209 in adult human subjects from 18 to 55 years with facial dark spots. The subject will be instructed to visit the facility as per the below visit.

Visit 1 (Day 1): Screening and Enrolled Day 1,

Visit 2 (Day 7): Product usage Period, Evaluation visit

Visit 3 (Day 14): Product usage Period, Evaluation visit

Visit 4 (Day 21): Product usage Period, Evaluation visit

Visit 5 (Day 28): Product usage Period End, End of the Study visit.

The main objective of this study is to determine the effectiveness of test products i.e. change in a facial dark spot, erythema, facial wrinkles, fine lines of crows feet area, skin texture, skin elasticity, skin oiliness, skin glow, skin hydration, skin barrier function, change in PGA scoring, change in Glogau skin age, change in skin type, change in facial photograph.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 42

Inclusion Criteria

1)Age: 18 to 55 years (both inclusive) at the time of consent.
2)Sex: Healthy non-pregnant/non-lactating females and Males.
3)Subject has facial dark spots preferably equal ratio of tan, blemishes, sunspots, and age spots.
4)Female of childbearing potential must have a reported negative pregnancy during screening.
5)Subject is generally in good health.
6)Subject is not undergone any cosmetic procedures or any medication for the treatment of acne 3 months prior to study enrolment.
7)Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
8)Willing to forgo use of all other topical acne medications or antibiotics during the study period or any treatment duration of the study 9)Subject is able to forgo changes in baseline medications and nutritional supplements, any other anti-acne facial cream, powder, face mask etc.
during the study period.
10)If the female 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.
11)Subject is willing not to introduce any new soaps, cleansers, lotions, creams, or any other face product etc.
for the duration of the study.
12)Subject is willing to give written informed consent and are willing to follow the study procedure.
13)The subject is willing to use test product throughout the study period.

Exclusion Criteria

1)Subject has a history of allergy or sensitivity to the test product ingredients.
2)Subject who has a history of allergy with products containing turmeric or any known ingredients.
3)Subject who has pre-existing or dormant dermatologic conditions (e.g., psoriasis rashes, eczema, seborrheic dermatitis, acne, acne rosacea or any other) that could interfere with the subject selection and outcome of the study as determined by the Investigator.
4)Subject has taken any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
5)Subject using any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
6)Subject is not willing to avoid unprotected sun or other UV radiation exposure during the study period.
7)Subject has a history of alcohol or drug addiction.
8)Subject has a history of prior use of scar removal, spots reduction, skin radiance or wrinkles laser treatment within 3 months.
9)Any other condition which could warrant exclusion from the study, as per the dermatologistâ€™s/Investigatorâ€™s discretion.
10)Subject has a history of chronic illness which may influence the cutaneous state.
11)Subjects participating in other similar cosmeceuticals, cosmetics or therapeutic trials or skin care products within the last 4 weeks.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in the	baseline Day01 before application to Day 01 (Instant readings at T0 i.e. 20 mins post application), Day 7, Day 14, Day21 and Day 28
1. facial dark spots	baseline Day01 before application to Day 01 (Instant readings at T0 i.e. 20 mins post application), Day 7, Day 14, Day21 and Day 28
2. Change in faical dark spot and erythema	baseline Day01 before application to Day 01 (Instant readings at T0 i.e. 20 mins post application), Day 7, Day 14, Day21 and Day 28
3.change in the facial wrinkles and fine lines of Crowâ€™s feet area, skin texture	baseline Day01 before application to Day 01 (Instant readings at T0 i.e. 20 mins post application), Day 7, Day 14, Day21 and Day 28
4.change in the facial skin elasticity	baseline Day01 before application to Day 01 (Instant readings at T0 i.e. 20 mins post application), Day 7, Day 14, Day21 and Day 28
5.change in the facial skin oiliness	baseline Day01 before application to Day 01 (Instant readings at T0 i.e. 20 mins post application), Day 7, Day 14, Day21 and Day 28
6.change in the facial skin hydration	baseline Day01 before application to Day 01 (Instant readings at T0 i.e. 20 mins post application), Day 7, Day 14, Day21 and Day 28
7.change in the facial skin glow	baseline Day01 before application to Day 01 (Instant readings at T0 i.e. 20 mins post application), Day 7, Day 14, Day21 and Day 28
8.change in the facial skin barrier functions	baseline Day01 before application to Day 01 (Instant readings at T0 i.e. 20 mins post application), Day 7, Day 14, Day21 and Day 28

Secondary Outcome Measures

Name	Time	Method
1. change in Physician Global Assessment	2. change in Glogau Skin Age

Trial Locations

Locations (1): NovoBliss Research Pvt. Limited
🇮🇳
Gandhinagar, GUJARAT, India
NovoBliss Research Pvt. Limited
🇮🇳Gandhinagar, GUJARAT, India
Dr Apeksha Merja
Principal investigator
79-48983895
dermatology@novobliss.in