Health Condition 1: L64- Androgenic alopecia
Conditions
Interventions
Intervention1: Fixed drug combination of Minoxidil 5% and Adenosine 1% topical solution: 1 ml topical application twice daily for study duration
Control Intervention1: Minoxidil 5% topical solution: 1
Sponsors
Dr Reddys Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects between 18 â?? 45 years of age, with a clinical diagnosis of Androgenetic Alopecia (AGA). 2. Male subjects exhibiting male pattern hair loss as described by Norwood-Hamilton Scale III vertex to V OR Female subjects exhibiting female pattern hair loss as described by Sinclair classification grade 2 to grade 4. 3. Subjects willing to provide written informed consent and comply with study instructions for its duration. 4. Subjects willing to maintain same hair style and colour through-out the study. 5. Females of child-bearing potential should have a negative urine pregnancy test prior to beginning therapy and agree to use adequate birth control during the study (acceptable methods include hormonal contraception maintained for a period of 3 months prior to the study and persisting through the study period, intrauterine device, barrier or abstinence).
Exclusion criteria
Exclusion criteria: 1. Subjects with known hypersensitivity to Minoxidil or Adenosine or any of the ingredients of the test drugs or tattoo ink. 2. Females who are pregnant, breast feeding, or planning a pregnancy during the proposed study period. 3. Any dermatological disorders of the scalp with the possibility of interfering with the clinical study related evaluation methods, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars or scalp atrophy. 4. Active hair loss or history within the past 3 months including diffuse telogen effluvium, alopecia areata, scarring alopecia. 5. Any severe, acute or chronic medical condition that may lead to hair loss or interfere with the interpretation of trial results. 6. Subjects who had hair transplant surgery, hair weaves or non-breathable wigs and hair bonding. 7. Use of any anti-hair loss treatment within the last 6 months prior to the screening visit including Minoxidil, Finasteride, Dutasteride or similar products. 8. Current use or history of use of systemic treatment (drugs or dietary supplement) taken for more than 2 consecutive weeks interfering with the study product or evaluations (Beta blockers, Cimetidine, Diazoxid, Isotretinoin, corticosteroids, Vitamin A intake above 10000 IU per day) within past 3 months. 9. Current use or history of use of local treatment (drug or cosmetically) on scalp interfering with the study product or evaluation (topical corticosteroids, Aminexil, Minoxidil, medicated shampoos, topical estrogen, topical Ketoconazole) within past 4 weeks. 10. Enrolled in any other investigational medication study currently, or within the last 6 months. 11. History of undergoing chemotherapy or receiving cytotoxic agents or radiation and/or laser/surgical therapy of the scalp within past 6 months. 12. Subjects with clinically significant cardiovascular, liver, lung, neurologic, renal or psychiatric disorder, or clinically significant laboratory abnormalities (if laboratory values exceed the threshold limits set out for this study, the approval of Medical Monitor should be taken into consideration before randomizing the subject). 13. Subjects with a history or examination findings of alcohol dependence, alcohol or drug abuse or suspected abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Target Area Hair Count (TAHC) as measured by Video dermoscope from baseline to Week 24.Timepoint: Baseline to week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| o Change in proportion of thick and thin hair from baseline to end of study o Subject satisfactory rate, as assessed by questionnaire at Week 24. o Investigator assessmentTimepoint: Baseline to week 24 | — |
Countries
India
Contacts
Public ContactSachin S Joshi
Dr. Reddyâ??s Laboratories Ltd.
Outcome results
None listed