Assessment of Efficacy and Safety of ST-Richduo (Tretinoin gel 0.1% with topical minoxidil 5%) in the Treatment of Androgenic Alopecia
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Percentage change in the proportion of anagen hair using frontal, temporal, and vertex trichoscopy in the treatment
Study Overview
Brief Summary
Background Summary
Androgenetic alopecia (AGA) is a common hair loss disorder influenced by hormones, genetics, and environmental factors, with a prevalence of 58% among Indian males aged 30-50. The condition involves the gradual transformation of terminal hairs to vellus hairs and is less prevalent in African Americans, Chinese, and Japanese populations compared to Caucasians. Minoxidil, an FDA-approved treatment, promotes hair regrowth but is only effective in 30-40% of users due to variations in the sulfotransferase enzyme (SULT1A1) activity, which converts minoxidil to its active form. Topical retinoids, such as all-trans-retinoic acid, have been shown to enhance minoxidil efficacy by promoting its sulfonation. Regaliz has developed "ST-Rich Duo," a combination of tretinoin gel 0.1% w/v and minoxidil 5%, to improve hair regrowth and density by enhancing minoxidil absorption.
Study purpose:
This study purpose is to evaluate the efficacy and safety of tretinoin gel 0.1% w/v and minoxidil 5% combination in patients with limited or no response to minoxidil treatment.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Male & Female, between 18-45 years of age diagnosed with AGA and MPHL.
- •2.Norwood-Hamilton grades II to V.
- •3.Ludwig grades I and II.
- •3.Clinically diagnosed as Minoxidil non responder / partial responder based on global photography assessment.
- •5.Minoxidil non responder / partial responder based on Minoxidil Response Test.
- •6.Able to give informed consent.
Exclusion Criteria
- •1.Subjects on isotretinoin, radiation to the scalp, or chemotherapy within past 1 year 2.Use of any other AGA treatment during past 6 months 3.Subjects on botanicals/nutraceuticals for hair regrowth for the past 3 months 4.Men with uncontrolled hypertension or history of hypotension 5.Any chronic active scalp condition other than AGA 6.History of scalp reduction or use of hair weaves 7.Pregnant or lactating women.
Outcomes
Primary Outcomes
Percentage change in the proportion of anagen hair using frontal, temporal, and vertex trichoscopy in the treatment
Time Frame: Baseline to 12 weeks of treatment
Secondary Outcomes
- Percentage change in the proportion of anagen hair using frontal, temporal, and vertex trichoscopy in the treatment(Assessment of global scalp photograph by investigator and subjects using 5 point scale (scale of 0â€4 (0: No improvement; 1: 1â€25% improvement; 2: 26â€50% improvement; 3: 51â€75% improvement; 4: 76â€100% improvement).)
Investigators
Dr B S Chandrashekar
CUTIS Academy of Cutaneous Sciences