A full face, randomized study to evaluate the efficacy and tolerance of regimen of Retinol Serum with Moisturizer versus Moisturizer alone in reducing early signs of ageing in Indian females over 8 weeks.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Improvement in early signs of ageing after usage of a regimen containing retinol in comparison to baseline.
Study Overview
Brief Summary
Skin of colour populations show varied signs of ageing as compared to populations of lighter complexions. Photoaging in Asians is commonly seen as hyperpigmentation, seborrheic dermatitis, melasma as compared to structural changes. Early signs of aging in the Skin of Colour (SOC) population often present differently compared to lighter skin tones. These signs include the appearance of hyperpigmentation, such as melasma or dark spots and wrinkles. SOC is also prone to changes in skin texture, including roughness and uneven tone. There are several treatment options to mitigate signs of ageing such as retinoids. This study aims to compare and evaluate a regimen of retinol with hyaluronic acid with hyaluronic acid alone in early ageing Indian women.
This study is planned to be a full face, randomized controlled comparative study and will be conducted over approximately 9 weeks and will include 6 visits. Visit 1- Screening visit, Wash out period 3 to 5days, Visit 2: Baseline visit (Week 0- W0), Visit 3: Week 1 (W1) assessment visit, Visit 4: Week 4 (W4) assessment visit, Visit 5: Week 8 (W8) assessment visit, Visit 6: 3 days (up to 5 days) after W8 assessment visit.
On the screening visit, subjects will be instructed to wash their face with cleanser and wait for approximately 1hour during which dermatological assessments will be performed.
On visits 2, 3, 4, 5, Imaging using VISIA CR, Antera, Dermatological assessments (for ageing, fine lines and wrinkles, skin texture and skin tone), Corneometer, Tewameter, cutometer, Visioscan, Sebumeter and self assessment questionnaires will be performed.
Test products and subject diary will be dispensed on visit 2 and subjects will be given instructions on their usage.
On visit 5, test products will be retrieved and subjects will be instructed to use the additional products for 3 additional days. On visit 6, similar dermatological, instrumental and imaging assessments will be performed to evaluate regression effects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Female subjects aged between 20-40 years (both ages inclusive)
- •Subjects who have not used retinol-based products minimum 8 weeks prior to enrollment.
- •Subjects who only use base moisturizer for a minimum at least 4 weeks prior to enrollment.
- •Subjects with self-declared non-sensitive skin and as confirmed by modified Baumann’s questionnaire with score less than
- •Subjects with roughness score of greater than or equal to 4 (0-9) measured by Dermatological Assessments.
- •Subjects with underneath eye wrinkles score of greater than or equal to 2 (grades 0-5) as per atlas measured by Dermatological Assessments.
- •Subjects with 1hour sebum secretion rate of more than 90 (oily skin) in each test group preferably in equal ratio.
- •Subjects with 1hour sebum secretion rate of less than 90 (non-oily skin) in each test group preferably in equal ratio.
- •Subjects with all skin types, preferably in equal ratio of normal, oily, dry and combination types as confirmed by general health screening form.
- •Subjects with Fitzpatrick phototype III, IV, V and VI as confirmed by general health screening form.
- •Subjects who agree not to use any other product or treatment or home remedy or except the provided products on their face during the study period.
- •Subjects who agree not to carry out bleaching or any other procedures including facial etc.
- •on face during the study period.
- •Subjects who agree not to expose to excessive direct sun light (sun exposure not more than half an hour daily and during that time use of umbrella to cover face).
- •Subjects willing to give a voluntary written informed consent, photography re-lease and agree to come for regular follow-up.
- •Subjects willing to abide by and comply with the study protocol.
Exclusion Criteria
- •Subjects who do not agree to abstain from other cosmetic products including colour cosmetics
- •Subjects who work outdoors and those with direct UV or sun exposure
- •Subjects with known skin conditions that may impact the assessment.
- •Subjects with any other signs of significant local irritation or skin disease.
- •Subjects currently taking any medication and/or taken medication within 30 days prior to the study, which the investigator believes may influence the interpretation of the data, such as but not limited to oral isotretinoin.
- •Subjects having clinically significant systemic or cutaneous disease, chronic illness or major surgery in the last year.
- •Subjects undergoing treatment of any skin condition on their face.
- •Subject who are allergic and/or have known sensitivity to any of the treatment products and or ingredients of the treatment products that will be provided.
- •Subjects who have participated in a similar clinical study 4 weeks before this study.
- •Subjects who are pregnant and/or planning to get pregnant and/or nursing and/or planning to nurse (self-declared).
- •Subjects who are on any kind of supplements or taking nutraceuticals.
- •Subjects who are employees of the sponsor or the CRO.
Outcomes
Primary Outcomes
Improvement in early signs of ageing after usage of a regimen containing retinol in comparison to baseline.
Time Frame: Baseline, Week 1, Week 4, Week 8, 3 days after week 8.
Secondary Outcomes
- 1. Improvement in early signs of ageing after using a regimen containing retinol in comparison to baseline.(2. Improvement in hydration and early signs of ageing after using the moisturizer in comparison to baseline)
Investigators
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd.