Health Condition 1: L909- Atrophic disorder of skin, unspecified
Conditions
Interventions
Intervention1: Tretin tretinoin 0.1%: Apply tretinoin 0.1% cream 1gr once daily on the full face
Control Intervention1: NA: NA
Sponsors
H&H Pharmaceutica LLP
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female subjects aged 35 to 70 years with visible signs of skin aging. 2.Subjects having one or more signs of aging such as wrinkles, fine lines, uneven skin tone, or mild pigmentation. 3.Subjects belonging to Fitzpatrick skin types III to V. 4.Subjects willing and able to comply with the study protocol and abstain from any anti-aging treatments or topical medications (other than the investigational product) during the 16-week study period. 5.Subjects must provide written informed consent prior to participation. 6.If using make-up, subjects must have used the same brand/type for at least 14 days prior to study entry and agree not to change the product or usage frequency during the study.
Exclusion criteria
Exclusion criteria: 1.Subjects with known hypersensitivity or allergy to tretinoin, retinoids, or any ingredients in the investigational product. 2.Women who are pregnant, lactating, or planning pregnancy during the study period. 3.Subjects with history of cosmetic or dermatologic procedures within 3 months prior to baseline (e.g., chemical peels, microdermabrasion). 4.Subjects intended to use anti-aging products (topical or oral) other than investigation product during the study. 5.Subjects who have active facial skin conditions that could interfere with evaluation (e.g., acne, eczema, psoriasis). 6.Subjects having baseline irritation score of 3 (severe) based on investigator s assessment. 7.Subjects with history of use of oral retinoids within 6 months before baseline or planned use during the study. 8.Subjects who used hormonal contraceptives within 3 months prior to baseline. 9.Subjects undergone prior laser therapy or phototherapy within the past 6 months to study entry. 10.Subjects who underwent cosmetic treatments (e.g., facials) within 14 days prior to study start that may influence study outcomes. 11.Subjects who are current smokers or history of tobacco use exceeding 10 pack-years. 12.Unstable, clinically significant, or life-threatening disease that may pose a risk to the subjects or affect the study results, as judged by the investigator. 13.Subjects who are regular engagement in activities involving prolonged sun exposure or exposure to extreme weather conditions (e.g., wind, cold). 14.Subjects who are engaged in alcohol consumption or use of recreational/abusive drugs (e.g., cannabinoids, cocaine, barbiturates).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in wrinkle severity score (Modified Griffiths Scale or WSRS) Improvement in skin texture (visual grading)Timepoint: After 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Wrinkle severity & photoaging grade were assessed using Antera 3D equipment. Melanin & erythema levels were measured using Dermatcatch. Sebum content was determined with a Sebumeter. Skin moisture was evaluated using a digital moisture analyzer (SK-IV). All the above parameters were assessed at baseline & at the end of the study (Week 16).Timepoint: After 4 months | — |
Countries
India
Contacts
Public ContactDr B S Chandrashekar
CUTIS Academy of Cutaneous Sciences
Outcome results
None listed