Arucha Treesirichod
Ongkharak, Changwat Nakhon Nayok, 26120, Thailand
NCT Number: NCT06213987
The goal of this randomized intra-individual design with a split-side axillary approach is to comparing the efficacy of 0.025% tretinoin cream against a cream-based formulation in the treatment of axillary hyperpigmentation associated with acanthosis nigricans.
The main questions it aims to answer are:
* The efficacy of 0.025% tretinoin cream and cream based in the treatment of axillary hyperpigmentation associated with acanthosis nigricans. * The safety of 0.025% tretinoin cream and cream based in the treatment of axillary hyperpigmentation associated with acanthosis nigricans.
Participants were randomly assigned to apply both 0.025% tretinoin cream and the cream-based product on opposing sides of the axillary region.
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Phase 3
Ongkharak, Changwat Nakhon Nayok, 26120, Thailand
This study employed a randomized intra-individual design with a split-side axillary approach, comparing the efficacy of 0.025% tretinoin cream against a cream-based formulation. Participants were randomly assigned to apply both 0.025% tretinoin cream and the cream-based product on opposing sides of the axillary region. The efficacy of treatment was assessed by Mexameter (melanin index). The investigator's global evaluation (IGE) and parent's global evaluation (PGE) were also used to evaluate the overall success rate. The local safety was conducted for assessment of any cutaneous irritation. At each visit, the investigator graded the degrees of erythema, dryness, peeling, burning, and itching using a scale of 0 to 4. This study was followed for 4 visits, at the baseline, at week 2, 4 and 8.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Total duration of 8 weeks.
Time frame: weeks 0, 2, 4 and week 8
The outcome was treatment efficacy in reducing skin pigmentation, as represented by changes in melanin indices from Mexameter MX18.
Time frame: weeks 0, 2, 4 and week 8
The outcomes were improvement in overall assessment using investigator global evaluation scales (IGE) and patient global evaluation scales (PGE), with scores ranging from 0 to 6 (0= clear, 1= almost clear or >90% improvement; 2= marked improvement or >75% improvement; 3= moderate improvement or >50% improvement; 4= mild improvement or >25% improvement; 5= no change; 6= worsening).
Time frame: weeks 0, 2, 4 and week 8
Adverse reactions were explored using the cutaneous irritation grading scales, in which participants rated erythema, dryness, peeling, burning each on a scale of 0 to 4, with 0 representing no adverse effect and 4 as marked severity.
Srinakharinwirot University
Other
A Control Trial of the Efficacy and Safety of 0.025% Tretinoin Cream and Cream Based in the Treatment of Axillary Hyperpigmentation Associated With Acanthosis Nigricans
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07371169
Acanthosis Nigricans, Glucose Metabolism Disorders
Baghdad, Baghdad Governorate, Iraq
View Trial DetailsNCT06940895
Acanthosis Nigricans, Hyperpigmentation
Brooklyn, New York, United States
View Trial DetailsNCT01881373
Acanthosis Nigricans, Behavior
Honolulu, Hawaii, United States
View Trial DetailsNCT06008327
Acanthosis Nigricans, Hyperpigmentation
Karachi, Sindh, Pakistan
View Trial Details