A Phase 3 interventional study of 0.025% Tretinoin in Acanthosis Nigricans and Hyperpigmentation, sponsored by Srinakharinwirot University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by Srinakharinwirot University · Phase 3, Interventional, and Treatment
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:
Participants were randomly assigned to apply both 0.025% tretinoin cream and the cream-based product on opposing sides of the axillary region.
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.
127 studies on the registry are indexed under Hyperpigmentation; 28 are open to participants now.
This study's enrollment of 20 is below the median of 32 across 113 interventional studies indexed under Hyperpigmentation.
Browse Hyperpigmentation studies →Srinakharinwirot University is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Apply 1 gram of tretinoin cream to the axillary region before bedtime once every other day during the first two weeks, and then once daily after that, total duration of 8 weeks.
Drug: 0.025% Tretinoin
Apply 1 gram of cream based to the axillary region on the opposing side before bedtime once every other day during the first two weeks, and then once daily after that, total duration of 8 weeks.
Drug: 0.025% Tretinoin
Total duration of 8 weeks.
Melanin index assessed by Mexameter
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
Global evaluation scales
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 cutaneous reactions
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.
Time frame: weeks 0, 2, 4 and week 8
Plan to share: Yes — In accordance with our commitment to transparency and advancing scientific knowledge, individual participant data collected during this study will be made available for sharing. The data will be accessible to qualified researchers upon request, subject to approval by the data sharing committee.
Supporting information: Study protocol
Time frame: The data release will occur no later than 12 months after the publication of the primary study outcomes.
Access criteria: Access to the data will be granted based on a set of predefined criteria, and interested parties will be required to submit a formal request outlining the purpose of data usage and plans for analysis. A data sharing agreement may be required to ensure compliance with ethical standards and the protection of participant privacy. For inquiries or to request access to the data, please contact trees_ar@yahoo.com
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Ran from Feb 2024 to primary completion in Jun 2024, 4 months.
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Studies of the drug tested here: Tretinoin
Srinakharinwirot University