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IRCT20260924071175N1 IRCT 2026-10-02 Shiraz University of Medical Sciences Comparison of a Topical Cannabidiol and Niacinamide Serum Plus Oral Doxycycline With Placebo Plus Oral Doxycycline for the Treatment of Moderate Acne Vulgaris Effect of a topical serum containing cannabidiol and niacinamide as an adjunct to oral doxycycline compared with topical placebo on the change in the number of inflammatory acne lesions from baseline to the end of the treatment period in patients with moderate acne vulgaris: a randomized, double-blind, placebo-controlled clinical trial 2026-10-23 anticipated 48 Recruiting https://irct.ir/trial/93643 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This is a single-center, add-on, placebo-controlled trial conducted at the Dermatology Department of Shiraz University of Medical Sciences. Both groups will receive oral doxycycline 100 mg once daily as standard treatment for moderate acne. In addition, the intervention group will apply a thin layer of a water-based serum containing cannabidiol, niacinamide, papain, and alpha-glucan oligosaccharide to the whole face, and the control group will apply an identical placebo serum in the same way, for 12 weeks. Participants will be instructed to apply the serum to clean, dry skin and to avoid any other anti-acne products. Outcomes will be assessed at baseline and after 12 weeks of treatment. Both the active and placebo serums are supplied free of charge by Persian Pod company, Randomization description: Participants will be individually randomized to the intervention or placebo group in a 1:1 ratio using permuted block randomization with a fixed block size of 4. No stratification will be applied. The random allocation sequence of 48 assignments (12 blocks of 4) will be generated with Random Allocation Software by a person independent of the research team who is not involved in recruitment, treatment, or outcome assessment. To conceal allocation, each assignment will be placed in a sequentially numbered, opaque, sealed envelope. Envelopes will be opened in order only after the participant has been enrolled and baseline assessments have been completed. The first author (Mohsen Olov) will enroll participants, and assignment to groups will be carried out by Dr. Mojdeh Sepaskhah according to the sealed envelopes, Blinding description: This is a double-blind trial. Participants and the outcome assessor (the dermatologist who counts lesions and determines GAGS scores) will be blinded to group allocation. The active serum and the placebo serum (water-based vehicle containing a viscosity-enhancing agent, a preservative, and fragrance, without any active ingredient) will be supplied by the manufacturer in identical containers with the same appearance, color, odor, and consistency, labeled only with codes. The allocation code list will be kept by a person outside the research team and will not be revealed until the end of data analysis, except in case of a serious adverse event requiring unblinding. The statistician will also analyze the data using coded groups. 3 Moderate acne vulgaris. Intervention 1: Intervention group: Oral doxycycline 100 mg capsule once daily, taken with at least one large glass of water, without lying down for half an hour afterward, and not with dairy products or calcium-containing supplements, plus 3 to 4 drops of a water-based topical serum containing cannabidiol, niacinamide, papain (a proteolytic enzyme), and alpha-glucan oligosaccharide (a prebiotic) applied as a thin layer to the whole face on clean, dry skin twice daily (morning and night) for 12 weeks. Other anti-acne products are not allowed during the study. The serum is manufactured and supplied free of charge by Persian Pod company. Ingredient concentrations have not been disclosed by the manufacturer for confidentiality reasons. Intervention 2: Control group: Oral doxycycline 100 mg capsule once daily with the same instructions as the intervention group, plus 3 to 4 drops of a placebo serum applied as a thin layer to the whole face on clean, dry skin twice daily (morning and night) for 12 weeks. The placebo serum is water-based and contains only a viscosity-enhancing agent, a preservative, and fragrance, without any active ingredient, and is identical to the active serum in appearance, color, odor, consistency, and packaging. Other anti-acne products are not allowed during the study. The placebo is manufactured and supplied free of charge by Persian Pod company. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mohammad Reza Namazi
Shiraz – Karim Khan Zand Boulevard – Adjacent to the School of Medicine – Dermatology Clinic, Shahid Faghihi Hospital.
Shiraz Iran (Islamic Republic of) ۷۱۳۴۸۴۶۱۱۴ +98 71 3235 1099 namazimr@sums.ac.ir Shiraz University of Medical Sciences scientific Mohammad Reza Namazi
Shiraz – Karim Khan Zand Boulevard – Adjacent to the School of Medicine – Dermatology Clinic, Shahid Faghihi Hospital.
Shiraz Iran (Islamic Republic of) ۷۱۳۴۸۴۶۱۱۴ +98 71 3235 1099 namazimr@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 40 yearst Clinical diagnosis of facial acne vulgaris by a dermatologist Moderate acne defined as a Global Acne Grading System (GAGS) score of 19 to 30 Eligible for treatment with oral doxycycline according to the dermatologis Willingness to avoid any other topical or systemic anti-acne product during the study Signing the written informed consent form 18 years 40 years Both Pregnancy, breastfeeding, or planning pregnancy Known hypersensitivity to tetracyclines Known hypersensitivity to cannabis products, niacinamide, papain, papaya, or any component of the serum Use of oral isotretinoin within the past 6 months use of oral antibiotics within the past 4 weeks Use of topical anti-acne medications within the past 2 weeks Starting or changing hormonal therapy (oral contraceptives, spironolactone) within the past 3 months Chemical peeling, laser, or other facial cosmetic procedures within the past 4 weeks Severe nodulocystic acne, acne conglobata, or acne fulminans Drug-induced acne or acne secondary to known endocrine disorders Other facial skin diseases such as rosacea, seborrheic dermatitis, or perioral dermatitis Known hepatic or renal disease Use of drugs with significant interaction with doxycycline, such as warfarin or systemic retinoids L70.0 Acne vulgaris Treatment - Drugs Treatment - Drugs Intervention group: Oral doxycycline 100 mg capsule once daily, taken with at least one large glass of water, without lying down for half an hour afterward, and not with dairy products or calcium-containing supplements, plus 3 to 4 drops of a water-based topical serum containing cannabidiol, niacinamide, papain (a proteolytic enzyme), and alpha-glucan oligosaccharide (a prebiotic) applied as a thin layer to the whole face on clean, dry skin twice daily (morning and night) for 12 weeks. Other anti-acne products are not allowed during the study. The serum is manufactured and supplied free of charge by Persian Pod company. Ingredient concentrations have not been disclosed by the manufacturer for confidentiality reasons. Control group: Oral doxycycline 100 mg capsule once daily with the same instructions as the intervention group, plus 3 to 4 drops of a placebo serum applied as a thin layer to the whole face on clean, dry skin twice daily (morning and night) for 12 weeks. The placebo serum is water-based and contains only a viscosity-enhancing agent, a preservative, and fragrance, without any active ingredient, and is identical to the active serum in appearance, color, odor, consistency, and packaging. Other anti-acne products are not allowed during the study. The placebo is manufactured and supplied free of charge by Persian Pod company. Number of inflammatory acne lesions (papules and pustules). Timepoint: At baseline (before intervention) and 12 weeks after the start of treatment. Method of measurement: Clinical counting of lesions by a dermatologist. : Number of non-inflammatory acne lesions (open and closed comedones). Timepoint: At baseline (before intervention) and 12 weeks after the start of treatment. Method of measurement: Clinical counting of lesions in specified facial areas by a dermatologist. . Timepoint: . Method of measurement: . Overall acne severity score. Timepoint: At baseline (before intervention) and 12 weeks after the start of treatment. Method of measurement: Global Acne Grading System assessed by a dermatologist. Incidence of adverse effects (itching, skin redness, worsening of lesions, irritation). Timepoint: During the 12-week treatment period and at 12 weeks after the start of treatment. Method of measurement: Physical examination and history taking by a dermatologist. Quality of life score of patients. Timepoint: At baseline (before intervention) and 12 weeks after the start of treatment. Method of measurement: Cardiff Acne Disability Index questionnaire (score 0 to 15). Shiraz University of Medical Sciences Approved 2026-08-25 Ethics committee of School of Medicine - Shiraz University of Medical Sciences School of Medicine, Shiraz University of Medical Sciences, Imam Hossein Square, Zand Street Shiraz Fars Iran (Islamic Republic of)